i

Solid Organ Transplantation and the Probability of 

Transmitting HIV, HBV, or HCV: A Systematic Review to 

Support an Evidence-based Guideline

Evidence-based Practice Center

ECRI Institute

Plymouth Meeting, Pennsylvania

April 14, 2010
ii

Acknowledgement

We would like to recognize Jonathan R. Treadwell, Ph.D., Senior Research Analyst, and Meredith Noble, 

M.S., Senior Research Analyst, from the Evidence-based Practice Center, ECRI Institute, Plymouth 

Meeting, PA, who authored this document.

We also would like to thank the following individuals who provided in-depth review of the key evidence 

search questions, bibliography resulting from the literature review, and the evidence outlined in this

document.

Blumberg, Emily, MD

Professor of Medicine; 

Director, Transplant Infectious Diseases;

University of Pennsylvania

Ison, Michael G, MD, MS

Associate Professor, Divisions of Infectious Diseases & Organ Transplantation;

Director, Transplant & Immunocompromised Host Infectious Diseases Service;

Northwestern University Feinberg School of Medicine

Preiksaitis, Jutta K, MD

Medical Director, Provincial Laboratory for Public Health;

Walter Mackenzie Health Science Centre
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Table of Contents

Introduction......................................................................................................................................1

Methodology....................................................................................................................................5

Search Strategy ......................................................................................................................................... 5

Inclusion Criteria....................................................................................................................................... 5

Quality Assessment................................................................................................................................. 12

GRADE Assessment............................................................................................................................... 15

Statistical Analysis.................................................................................................................................. 16

Evidence Tables...................................................................................................................................... 16

Overview of the Evidence..............................................................................................................18

Evidence Reviews: I. Probability of transmission of HIV, HBV, or HCV through solid 

organ transplantation (SOT) ..........................................................................................................20

Question 1. What are the prevalence and incidence rates of HIV, HBV, and HCV among 

potential solid organ donors? .................................................................................................................. 20

Potential Organ Donors ...................................................................................................................... 20

Pre-1991 Organ Donors Retrospectively Tested for HCV ................................................................. 24

Potential Tissue Donors...................................................................................................................... 26

General Population ............................................................................................................................. 28

GRADE Assessment of Epidemiology............................................................................................... 29

Additional Evidence Tables for Question 1........................................................................................ 33

Question 2. What are the rates of transmission to recipients from donors infected with HIV, 

HBV, or HCV? Do the rates vary by the organ transplanted or when the donor was infected?............. 34

HBV Transmission from Liver Transplantation ................................................................................. 37

HBV Transmission from Kidney Transplantation.............................................................................. 42

HBV Transmission from Heart Transplantation................................................................................. 45

HBV Transmission from Lung Transplantation ................................................................................. 46

HCV Transmission from Liver Transplantation ................................................................................. 46

HCV Transmission from Kidney Transplantation.............................................................................. 48

HCV Transmission from Heart Transplantation................................................................................. 50

GRADE Assessment of Transmission................................................................................................ 52

Additional Evidence Tables for Question 2........................................................................................ 59

Evidence Reviews: II. Methodology to better estimate donor infection with HIV, HBV, or 

HCV...............................................................................................................................................96
iv

Question 3. What behavioral risk factors are associated with an increased probability of infection 

with HIV, HBV, or HCV? What is the prevalence of these characteristics among potential solid 

organ donors?.......................................................................................................................................... 96

And .................................................................................................................................................96

Question 4. What nonbehavioral risk factors are associated with an increased probability of 

infection with HIV, HBV, or HCV? What is the prevalence of these factors among potential solid 

organ donors?.......................................................................................................................................... 96

Studied Populations and Study Methods .......................................................................................... 100

Analysis Methods ............................................................................................................................. 126

Assessment of Risk of Bias (Quality of Study Design): Identification of Risk Factors................... 127

Assessment of Risk of Bias (Quality of Study Design): Prevalence of Risk Factors....................... 131

GRADE Assessment of Identification of Risk Factors..................................................................... 132

GRADE Assessment of Prevalence of Risk Factors......................................................................... 133

Question 3: Results............................................................................................................................... 134

Exclusionary Behavioral Criteria from 1994 Guideline ................................................................... 134

Additional Potential Risk Factors Identified in the 2009 Literature Search ..................................... 140

Evidence Tables for Question 3........................................................................................................ 147

Question 4: Results............................................................................................................................... 204

Exclusionary Criteria from 1994 Guideline...................................................................................... 204

Additional Potential Risk Factors Identified in the 2009 Literature Search ..................................... 205

Evidence Tables for Question 4........................................................................................................ 213

Question 5. What are the test characteristics of the screening methods available to detect HIV, 

HBV, and HCV in potential solid organ donors? Do test characteristics differ in particular 

populations and with donor clinical status (i.e., heart beating vs. non-heart beating donors OR 

adult vs. pediatric donors)? ................................................................................................................... 295

Samples and Study Methods in Peer-reviewed Publications............................................................ 318

Analysis Methods ............................................................................................................................. 338

Assessment of Peer-reviewed Studies .............................................................................................. 340

Results............................................................................................................................................... 354

Evidence Reviews: III. Donor interventions to decrease transmission of HIV, HBV,or HCV 

from infected donors....................................................................................................................399

Question 6. Which donor interventions reduce the probability of pathogen transmission from an 

organ donor infected with HIV, HBV, or HCV to a previously uninfected recipient?......................... 399

Evidence Reviews: IV. Potential risks and benefits of transplanting, or not transplanting, 

solid organs from donors positive for HIV, HBV, or HCV.........................................................403

Question 7. How do the clinical outcomes of recipients of organs from donors infected with HIV, 

HBV, or HCV compare to those who remain on the transplant list? .................................................... 403

Organs from Positive Donors Compared to Remaining on the Waitlist........................................... 404

Organs from Positive Donors Compared to Organs from Negative Donors When the Recipients 

were Negative Before Transplant ..................................................................................................... 408
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Organs from Positive Donors Compared to Organs from Negative Donors When the Recipients 

were Positive Before Transplant....................................................................................................... 410

Additional Evidence Tables for Question 7...................................................................................... 421

Evidence Reviews: V. Potential risks and benefits of transplanting, or not transplanting, 

solid organs from donors with risk factors for HIV, HBV, or HCV ...........................................475

Question 8. How do the clinical outcomes of transplant recipients who receive organs from 

donors with behavioral or nonbehavioral risk factors compare to those who remain on the 

transplant list? ....................................................................................................................................... 475

Question 9. What is the impact of excluding potential solid organ donors with behavioral or 

nonbehavioral risk factors on the organ donor pool?............................................................................ 488

Question 10. What is the impact of false positive tests on the organ donor pool?................................ 489

Gaps in the Current Literature .....................................................................................................490

References....................................................................................................................................491

Appendix A..................................................................................................................................503

Details of Literature Search .................................................................................................................. 503
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Tables

Table 1. Questions for Systematic Review .............................................................................................1

Table 2. Original Question-Specific Inclusion Criteria ..........................................................................6

Table 3. Modified Question-Specific Inclusion Criteria.........................................................................7

Table 4. Diagnostic Tests of Interest for Question 5.............................................................................10

Table 5. Quality Assessment Criteria....................................................................................................12

Table 6. Interpretation of GRADE Ratings...........................................................................................15

Table 7. Prevalence of Hepatitis and HIV among Potential Organ Donors..........................................22

Table 8. Prevalence of HCV among Pre-1991 Organ Donors..............................................................24

Table 9. Prevalence of Hepatitis and HIV Among Potential Tissue Donors........................................27

Table 10. Methods of Studies Included on Incidence and Prevalence in the U.S. General Population..28

Table 11. Incidence and Prevalence of HBV and HCV in the U.S. General Population........................29

Table 12. GRADE Table for Question 1 (Epidemiology) ......................................................................30

Table 13. Question 1: Quality Assessment .............................................................................................33

Table 14. LIVER Transplantation: Ranges of HBV Results ..................................................................38

Table 15. KIDNEY Transplantation: Ranges of HBV Results...............................................................42

Table 16. HEART Transplantation: Ranges of HBV Results.................................................................45

Table 17. LUNG Transplantation: Ranges of HBV Results...................................................................46

Table 18. LIVER Transplantation: Ranges of HCV Results ..................................................................46

Table 19. KIDNEY Transplantation: Ranges of HCV Results...............................................................48

Table 20. HEART Transplantation: Ranges of HCV Results.................................................................50

Table 21. GRADE Table for Question 2 (Transmission)........................................................................53

Table 22. Question 2: General Information about Included Studies.......................................................59

Table 23. Question 2: Details of Study Methods....................................................................................66

Table 24. Question 2: Pre-transplant Patient Characteristics..................................................................78

Table 25. Question 2: Quality Assessment .............................................................................................85
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Table 26. Question 2: Data Table of Results ..........................................................................................87

Table 27. Included Studies, Questions 3 and 4 .......................................................................................98

Table 28. Study Protocols for Questions 3 and 4..................................................................................102

Table 29. Participant Characteristics for KQ 4 and 5 ...........................................................................116

Table 30. Risk of Bias Assessment Items for Questions 3 and 4: Identification of Risk Factors.........127

Table 31. Quality Assessment for Questions 3 and 4: Identification of Risk Factors ..........................129

Table 32. Quality Assessment for Questions 3 and 4: Prevalence of Risk Factors ..............................131

Table 33. HBV Identification of Behavioral Risk Factors Data ...........................................................147

Table 34. HCV Identification of Behavioral Risk Factors Data ...........................................................159

Table 35. HIV Identification of Behavioral Risk Factors Data.............................................................180

Table 36. GRADE Table for Question 3 (Behavioral Risk Factors).....................................................186

Table 37. Prevalence of Behavioral Risk Factors.................................................................................198

Table 38. GRADE Table for Question 3: Prevalence of Behavioral Risk Factors...............................201

Table 39. HBV Nonbehavioral Risk Factors ........................................................................................213

Table 40. HCV: Nonbehavioral Risk Factors.......................................................................................231

Table 41. HIV: Nonbehavioral Risk Factors.........................................................................................268

Table 42. GRADE Table for Question 4 (Nonbehavioral Risk Factors) ..............................................276

Table 43. Prevalence of Nonbehavioral Risk Factors among Potential Organ Donors........................293

Table 44. GRADE for Question 4: Prevalence of Nonbehavioral Risk Factors...................................294

Table 45. Included Data Sets from Peer-reviewed Publications...........................................................297

Table 46. Included Data Sets from Gray Literature..............................................................................314

Table 47. General Study and Sample Characteristics of Peer-reviewed Studies..................................319

Table 48. Determining Diagnostic Performance...................................................................................339

Table 49. Study Design Items for Diagnostic Performance..................................................................342

Table 50. Quality Assessment of Question 5: Diagnostic Characteristics............................................348

Table 51. Summary of Turnaround Times............................................................................................355
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Table 52. Summary of Window Periods and Related Data...................................................................356

Table 53. Summary of Sensitivity and Specificity Data (Range of Reported Point Estimates) ...........357

Table 54. Overview of Diagnostic Tests...............................................................................................358

Table 55. Diagnostic Characteristics.....................................................................................................377

Table 56. GRADE Table for Question 5: Diagnostic Performance (Sensitivity/Specificity)...............387

Table 57. Inactivation Methods in Zucker et al. (1994)........................................................................400

Table 58. Inactivation Results in Zucker et al. (1994)..........................................................................401

Table 59. Question 6: Quality Assessment ...........................................................................................401

Table 60. GRADE Table for Question 6 (Inactivation)........................................................................402

Table 61. Baseline Characteristics in the Abbott et al. (2004) Study ...................................................406

Table 62. Large Pre-transplant Differences between Recipients of D+ and D- Organs in Studies of Pretransplant Positive Recipients...................................................................................................................411

Table 63. GRADE Table for Question 7 (Clinical Outcomes of Known Positive Organs vs. Waitlist or 

Known Negative Organs) .........................................................................................................................417

Table 64. Question 7: General Information about Included Studies.....................................................421

Table 65. Question 7: Details of Study Methods..................................................................................424

Table 66. Question 7: Pre-transplant Patient Characteristics................................................................428

Table 67. Question 7: Quality Assessment ...........................................................................................448

Table 68. Question 7: Reported Data....................................................................................................449

Table 69. Assumptions in the Schweitzer et al. (2007) Model .............................................................478

Table 70. HIV Epidemiology Assumptions in the Schweitzer et al. (2007) Model..............................480

Table 71. HCV Epidemiology Assumptions in the Schweitzer et al. (2007) Model ............................480

Table 72. Base Case Results of the Schweitzer et al. (2007) Model.....................................................481

Table 73. HIV and HCV Infection Results in Recipients of Kidneys from CDC-IRD Donors............482

Table 74. Waitlist Mortality Estimates by Freeman and Cohen (2009)................................................484

Table 75. Questions 8/9: Quality Assessment.......................................................................................485

Table 76. GRADE Table for Question 8 (Clinical Outcomes of At-risk Organs vs. Waitlist or Not-atrisk Organs)486
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Table 77. Electronic Databases Searched .............................................................................................503
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Figures

Figure 1. Analytic Framework .................................................................................................................4

Figure 2. Study Attrition Diagram..........................................................................................................19

Figure 3. Question 2: Plot of Transplantation Dates..............................................................................36

Figure 4. LIVER Transplantation: HBV Positivity in Recipients After the Use of Anti-HBc+ Donors40

Figure 5. LIVER Transplantation: HBV Positivity in Recipients After the Use of Organs from 

Anti-HBc+ HbsAg- Donors........................................................................................................................41

Figure 6. KIDNEY Transplantation: HBV Positivity in Recipients After the Use of Organs from 

Anti-HBc+ Donors or Anti-HBc+ HbsAg- Donors....................................................................................43

Figure 7. Other Results for HBV............................................................................................................44

Figure 8. LIVER transplantation: HCV Positivity in Recipients After the Use of Organs Donors 

Positive for HCV.........................................................................................................................................47

Figure 9. KIDNEY Transplantation: HCV Positivity in Recipients After the Use of Organs from 

Donors Positive For HCV...........................................................................................................................49

Figure 10. HEART Transplantation: HCV Positivity in Recipients After the Use of Organs from 

Donors Positive for HCV............................................................................................................................51

Figure 11. Adjusted Mortality Results of Transplanting Kidneys from DHCV+ Donors Compared to 

the Waitlist 407

Figure 12. Clinical Outcomes of Negative Recipients: Positive vs. Negative Donors, any Pathogen, 

any Organ 409

Figure 13. Clinical Outcomes of Positive Recipients: Positive vs. Negative Donors, HBV, Kidney or 

Liver 414

Figure 14. Clinical Outcomes of Positive Recipients: Positive vs. Negative Donors, HCV, Kidney 415

Figure 15. Clinical Outcomes of Positive Recipients: Positive vs. Negative Donors, HCV, Liver...416
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Introduction

This systematic review addressed 10 Questions (middle column of Table 1) pertaining to solid organ 

transplantation and three bloodborne pathogens (HIV, HBV, and HCV). These questions were carefully 

developed by the Centers for Disease Control and Prevention in consultation with the Center for 

Evidence-based Practice at the University of Pennsylvania and ECRI Institute. These questions are not 

intended to encompass all important issues related to infectious diseases and organ transplantation. 

Instead, they were specifically focused to support the development of an evidence-based guideline.

The leftmost column of the table shows which section of the guideline pertains to the questions, and the 

rightmost column provides explanatory comments.

Table 1. Questions for Systematic Review

Major topic area of the 

guideline

Question for Systematic 

Review Comments

I. Probability of 

transmission of HIV, 

HBV, or HCV through 

solid organ 

transplantation (SOT)

1. What are the prevalence 

and incidence rates of HIV, 

HBV, and HCV among 

potential solid organ 

donors?

This question addresses the extent of the 

possible problem. The focus is on the 

epidemiology rates for each of the three 

pathogens among people who are being 

considered for solid organ donation.

2. What are the rates of 

transmission to recipients 

from donors infected with 

HIV, HBV, or HCV? Do the 

rates vary by the organ 

transplanted or when the 

donor was infected?

A key concern is that a solid organ donor 

will transmit infection to a recipient. This 

question concerns the specific situation 

when the donor is positive for a pathogen 

but the recipient is not, and what 

percentage of such recipients become 

infected after transplantation.

II. Methodology to better 

estimate donor

infection with HIV, 

HBV, or HCV

3. What behavioral risk factors 

are associated with an 

increased probability of 

infection with HIV, HBV, or 

HCV? What is the 

prevalence of these 

characteristics among 

potential solid organ 

donors? 

Some behaviors may be associated with 

infection of HIV, HBV or HCV, and the 

first half of the question attempts to 

identify these behaviors. This is 

accomplished by comparing the rate of 

infection among those who do engage in 

a behavior to the rate of infection among 

those who do not. The second half 

addresses the frequency of those 

behaviors among potential solid organ 

donors.

4. What nonbehavioral factors 

are associated with an 

increased probability of 

infection with HIV, HBV, or 

HCV? What is the 

prevalence of these factors 

among potential solid organ 

donors? 

This is similar to the previous question, 

except here the focus is on 

nonbehavioral factors. Our primary intent 

was to identify signs and symptoms of 

incident infections (i.e., recently 

acquired), but we also included data on 

signs and symptoms of chronic infection, 

medical comorbidities, socioeconomic 

information, and demographic factors.

5. What are the test 

characteristics of the 

screening methods 

Numerous tests exist to detect HIV, HBV 

and/or HCV in potential donors, and this 

question concerns the diagnostic 
2

Major topic area of the 

guideline

Question for Systematic 

Review Comments

available to detect HIV, 

HBV, and HCV in potential 

solid organ donors? Do test 

characteristics differ in 

particular populations and 

with donor clinical status 

(i.e., heart beating vs. nonheart beating donors OR 

adult vs. pediatric donors)?

accuracy of those tests, as well as the 

length of the window period and the 

turnaround time. The window period is 

particularly important in this context, 

because an infected individual in the 

window period would not be detectable 

prior to donation of solid organs.

III. Donor interventions to 

decrease transmission 

of HIV, HBV,or HCV 

from infected donors

6. Which donor interventions 

reduce the probability of 

pathogen transmission from 

an organ donor infected 

with HIV, HBV, or HCV to a 

previously uninfected 

recipient?

Given an infected organ donor, it may be 

possible to inactivate the virus prior to 

transplantation into a recipient. This 

question seeks to identify effective 

methods for inactivation of viruses in 

solid organs donors.

IV. Potential risks and 

benefits of 

transplanting, or not 

transplanting, solid 

organs from donors 

positive for HIV, HBV, 

or HCV

7. How do the clinical 

outcomes of recipients of 

organs from donors infected 

with HIV, HBV, or HCV 

compare to those who 

remain on the transplant 

list?

This question concerns whether a patient 

will live longer after 1) receiving a known 

infected organ or 2) remaining on the 

transplant list. Other clinical outcomes of 

interest include graft survival and quality 

of life.

V. Potential risks and 

benefits of 

transplanting, or not 

transplanting, organs 

from donors with risk 

factors for HIV, HBV, 

or HCV

8. How do the clinical 

outcomes of transplant 

recipients who receive 

organs from donors with 

behavioral or nonbehavioral

risk factors compare to 

those who remain on the 

transplant list?

This question is conceptually similar to 

question 7. Here, however, the donor is 

not known to be infected, but the donor is 

at risk for infection based on a behavioral 

or clinical factor. As in question 7, the 

comparison is between implanting or not 

implanting organs from such donors, with 

a focus on clinical outcomes 

(e.g., recipient survival).

9. What is the impact of 

excluding potential solid 

organ donors with 

behavioral or nonbehavioral

risk factors on the organ 

donor pool?

If at-risk donors are excluded, one 

negative consequence is a reduction in 

the organ donor pool. This question 

attempts to quantify the size of the 

reduction.

10. What is the impact of false 

positive tests on the organ 

donor pool?

If donors testing positive are excluded 

from the donor pool, then false positives 

will result in an inappropriate reduction of 

the donor pool; this question attempts to 

quantify the size of the reduction.

The questions are depicted in an analytic framework (Figure 1) on the next page. The patient population

of interest is candidates for solid organ transplantation. The availability of such organs can be influenced 

by numerous factors depicted in the lower half of the figure, notably the infection status of the donor, and 
3

donor behavioral and nonbehavioral risk factors. In this framework, each candidate either 1) receives an 

organ or 2) remains on the waitlist. The clinical outcomes of interest include patient survival, graft 

survival, quality of life and recipient infection status.

The rest of this document is divided into numerous sections, as follows:

• Methodology, wherein we describe the methods used for conducting the systematic review

• Overview of the evidence, which paints a broad portrait of the included evidence

• Evidence for each question, which is divided into 10 sections. All text and evidence tables for a 

given question are collated together with that question. Thus, there are no appendices of evidence 

tables.

• Gaps in the current literature, which discussed the primary areas where further research is 

necessary

• References, which provides the full bibliography of included evidence

• Details of literature search, which provides the search strategies we employed
4

Figure 1. Analytic Framework

Potential solid organ donors

Patient

Population

Serological Test

Behavioral

Risk Factor 

Non-behavioral

Risk Factor 

4

Outcomes

Donor

Pool

9 Note: Circled numbers, e.g., 

denote questions addressed by 

the systematic review.

1

Inactivation

Remain on 

Wait List

Receive 

Solid Organ 

Transplant

2

Candidates 

for Solid 

Organ 

Transplant

Survival/ 

Mortality

Recipient 

infection 

status

Intervention Organ 

Availability

Quality of 

Life

Exclusion Exclusion

7

Exclusion Exclusion

Graft 

Survival

3

1

False 

negative

True 

positive

False 

positive

True 

negative 10

8

6

9 5
5

Methodology

Search Strategy

We searched six bibliographic databases including MEDLINE, EMBASE, and the Cochrane 

Library to identify clinical trials and other relevant publications. (All searched databases are 

listed in Table 77 of Appendix A.) Separate date limits were used for some questions, although 

most spanned 1990 through 2009. Mechanisms used to retrieve additional relevant information 

included review of bibliographies/reference lists from peer reviewed and gray literature. 

(Gray literature consists of reports, studies, articles, and monographs produced by federal and 

local government agencies, private organizations, educational facilities, consulting firms, and 

corporations. These documents do not appear in the peer-reviewed journal literature.)

Alphabetical lists of the concepts searched and detailed search strategies are provided in

Appendix A (Details of Literature Search).

Inclusion Criteria

The following universal criteria were applied to all Questions for Systematic Review

• English language

• Peer-reviewed, full-length publication with original data

• Multiple publications of the same study were treated as a single study rather than as multiple 

studies to avoid double-counting patients.

• The study included at least one of the following bloodborne pathogens: HIV, HBV, and HCV.

• The determination of the presence or absence of HIV/HBV/HCV must have been based on 

laboratory test(s), rather than subjective estimates, physician interviews, or patient interviews.

Additional criteria were applied on a per-question basis, as depicted in Table 2 on the next page.

For many questions, an insufficient number of studies was identified to support the development of the 

guideline. Consequently, in an effort to provide a sufficient amount of relevant information to support the 

development of the guideline, committee members expanded the inclusion criteria in multiple iterations 

over several months. The final question-specific inclusion criteria are shown in Table 3. The specific 

diagnostics tests of interest for Question 5 are listed in Table 4.
6

Table 2. Original Question-Specific Inclusion Criteria

Inclusion Criteria*

Questions for Systematic Review

1 2 3 4 5 6 7 8 9 10

Pertinent data on at least five people          

Data collected in U.S.A.      

Potential organ donors    

Rates not restricted to actual donors 

Not voluntary reporting 

Regardless of symptoms 

Data collected in year 2000 or later    

Donor seropositive pre-transplant   

Recipient seronegative pre-transplant  

Single type of organ, or separated data on different types of organs    

Waitlist control group  

Systematic review  

Addressed test sensitivity and specificity  

Experimental group with inactivation procedure 

Control group without an inactivation procedure 

Donor+ for behavioral or clinical factor pre-transplant 

*For each Question for Systematic Review, five universal criteria were also applied (see text). A checkmark in a given column means that a study must have met 

that criterion in order to be included for the numbered Question for Systematic Review.
7

Table 3. Modified Question-Specific Inclusion Criteria

Inclusion Criteria*

Questions for Systematic Review

1 2 3 4 5 6 7 8 9 10

Pertinent data on at least five people         

Data collected in U.S.A.    

Rates not restricted to actual donors 

At least one of four populations: 1) Potential organ donors; 2) organ donors with samples taken 

prior to 1992 that were retrospectively tested for HCV; 3) potential tissue donors; or 4) the 

general population (for this last population, we included only the most up-to-date 

epidemiological estimates)



Regardless of symptoms  

Donor seropositive pre-transplant   

Recipient seronegative pre-transplant 

Single type of organ, or separated data on different types of organs   

Waitlist control OR Control is recipients of organs from uninfected donors 

If pre-transplant infected recipients and pre-transplant uninfected recipients were included, the 

study must have reported separate outcome data on these two types of recipients.



Reported patient survival, graft survival, or quality of life.  

At least one of four populations, enrolling individuals of any age: 1) Potential organ donors; 

2) potential tissue donors; 3) potential blood donors; or 4) a sample representative of the 

general population (i.e., population unselected for any particular demographic, occupational, or 

behavioral characteristics, or health status other than HCV, HBV, or HIV infection status)

 

A study of a specific demographic or socioeconomic subpopulation was included for HBV, but 

excluded for HIV and HCV.

 

A study of a specific subpopulation of patients who were all selected for having the same 

behavioral risk factor was excluded for all three pathogens.

 
8

Inclusion Criteria*

Questions for Systematic Review

1 2 3 4 5 6 7 8 9 10

Article must have been published in 1990 or later if pertinent to HIV or HCV, or 1966 or later 

if pertinent to HBV.

 

In order to identify risk factors for the pathogen, study must have enrolled people with the risk 

factor as well as people without the risk factor; similarly, the study must have enrolled people 

positive for the pathogen as well as people negative for the pathogen.

 

For identification of clinical signs and symptoms that may indicate infection, data may be from 

any country. For identification of co-morbidities or demographic factors that may be associated 

with infection, data must be from U.S only.



Reported at least one of the diagnostic tests listed in Table 4. 

Reported at least one of the following:

• Sensitivity and specificity 

• Positive and negative predictive values (clinical populations only)

• Positive and negative likelihood ratios (clinical populations only)

• Sufficient data to calculate the above 

• Window period

• Turnaround time



Reported data on an individual test basis rather than multiple tests or algorithms. 

Inactivation procedure performed before transplant on organs obtained from infected 

individuals.



Donor positive pre-transplant for behavioral risk factor or signs/symptoms risk factor or 

comorbidity risk factor.



Waitlist control OR Control is recipients of organs from donors without that risk factor. 

Reported the number of organs that would not be included in the organ pool if donors with 

behavioral or nonbehavioral risk factors identified in questions 3 and 4 were excluded.



Reported the number of organs that would not be included in the organ pool if false positives 

were excluded.


9

*For each Question for Systematic Review, five universal criteria were also applied (see text). A checkmark in a given column means that a study must have met 

that criterion in order to be included for the numbered Question for Systematic Review.
10

Table 4. Diagnostic Tests of Interest for Question 5

Virus Test Name Manufacturer

Tests Currently in Use by U.S. Organ Procurement Organizations

HIV Genetics System (GS) HIV-1/HIV-2 Plus 0 EIA Bio-Rad Laboratories

HIVAB HIV-1/HIV-2 (rDNA) EIA Abbott Laboratories

HBV (HBsAg; the 

surface antigen)

Abbott PRISM HbsAg Assay Abbott Laboratories

ADVIA Centaur HbsAg Assay Siemens Healthcare Diagnostics

AxSYM HBsAg Abbott Laboratories

Genetic Systems (GS) HBsAg EIA 3.0 Bio-Rad Laboratories

HBV (anti-HBs; 

antibodies to the 

surface antigen)

Ortho Antibody to HbsAg ELISA Test System 3 Ortho Clinical Diagnostics

HBV (anti-HBc; 

antibodies to the core 

antigen)

Abbott PRISM HBcore Abbott Laboratories

ADVIA Centaur HBc Total Assay Siemens Healthcare Diagnostics

AxSYM Core 2.0 Abbott Laboratories

CORZYME Abbott Laboratories

Ortho HBc ELISA Test System Ortho Clinical Diagnostics

HCV Abbott HCV EIA 2.0 Abbott Laboratories

ADVIA Centaur Anti-HCV Siemens Healthcare Diagnostics

AxSYM Anti-HCV Abbott Laboratories

Ortho HCV Version 3.0 ELISA Test System Ortho Clinical Diagnostics

HIV NAT COBAS AmpliScreen HIV-1 Test v. 1.5 Roche Diagnostics

HCV NAT COBAS AmpliScreen HCV Test v. 2.0 Roche Diagnostics

HBV NAT COBAS AmpliScreen HBV Test Roche Diagnostics

HCV and HIV-1 NAT ProCleix HIV-1/HCV Assay Gen-Probe Incorporated

Fourth Generation Tests

HIV ARCHITECT HIV Combo Abbott Laboratories

AxSYM HIV Ag/Ab Combo Abbott Laboratories

COBAS Core HIV Combo Roche Diagnostics

Coulter HIV-1 p24 Antigen Assay Coulter Corporation

Enzygnost HIV Integral II Siemens Healthcare Diagnostics

Genscreen Plus HIV Ag/Ab Combo Bio-Rad Laboratories

Genscreen HIV Ultra Ag-Ab Assay Bio-Rad Laboratories

Murex HIV Ag/Ab Combo Abbott Laboratories

Modular HIV Combo Roche Diagnostics

VIDAS DUO ULTRA bioMerieux Clinical Diagnostics

VIDAS DUO QUICK bioMerieux Clinical Diagnostics

Vironostika HIV Uni-Form II Ag/Ab bioMerieux Clinical Diagnostics
11

Virus Test Name Manufacturer

HCV INNOTEST HCV Ab IV Innogenetics NV

Monolisa HCV Ag/Ab Ultra Bio-Rad Laboratories

Murex 4.0 Abbott Laboratories

EIA or ELISA– Enzyme-linked immunosorbent assay

NAT – Nucleic acid test
12

Quality Assessment

In order to assess the quality of the data for each Question for Systematic Review, we applied the criteria 

listed in Table 5. Due to substantial differences among the questions, we generally used different criteria

for each question. These criteria were determined after examining existing instruments for quality 

assessment and selecting the most appropriate items.

Table 5. Quality Assessment Criteria

Question Quality Criteria

1. What are the prevalence and incidence rates 

of HIV, HBV, and HCV among potential solid 

organ donors?

1a. Was the population potential solid organ 

donors?

1b. For other populations, was the population 

unselected (i.e., not based on demographic or 

behavioral characteristics)? (studies of 

potential solid organ donors were scored as 

Yes, because they enrolled the population of 

interest))

1c. Was infection status determined accurately? 

(i.e., accuracy of diagnostic test method used 

to determine infection status)

2. What are the rates of transmission to 

recipients from donors infected with HIV, 

HBV, or HCV? Do the rates vary by the organ 

transplanted or when the donor was infected?

2a. Was the study planned prospectively 

(i.e., before any data were collected)

2b. Were all consecutive patients enrolled 

(or a random sample of eligible patients)?

2c. Were laboratory tests performed on recipients 

regularly in order to monitor 

antigens/antibodies? (greater frequency 

means greater accuracy at estimating the 

rate) 

2d. Did all patients receive the same prophylaxis 

strategy (or none received any prophylaxis)? 

(a mix of prophylaxis strategies means a less 

interpretable rate)
13

Question Quality Criteria

3. What behavioral risk factors are associated 

with an increased probability of infection with 

HIV, HBV, or HCV? What is the prevalence of 

these characteristics among potential solid 

organ donors? 

3a. Was the population potential solid organ 

donors?

3b. For other populations, was the population 

unselected (i.e., not based on demographic or 

behavioral characteristics)? Were infected 

and uninfected participants similar on other 

risk factors?

3c. Were infected and uninfected participants 

similar on other risk factors?

3d. If not, were statistical adjustments performed 

to control for other risk factors?

3e. Was risk factor data collected in a valid 

manner (e.g., confidential or anonymous 

collection of sensitive risk factor data, 

collection of personal information from the 

person directly instead of someone else)

3f. Was infection status determined accurately? 

(i.e., accuracy of diagnostic test method used 

to determine infection status)

4. What nonbehavioral factors are associated 

with an increased probability of infection with 

HIV, HBV, or HCV? What is the prevalence of 

these factors among potential solid organ 

donors? 

Same as Question 3

5. What are the test characteristics of the 

screening methods available to detect HIV, 

HBV, and HCV in potential solid organ 

donors? Do test characteristics differ in 

particular populations and with donor clinical 

status (i.e., heart beating vs. non-heart 

beating donors OR adult vs. pediatric 

donors)?

5a. For measures of diagnostic performance other 

than window period detection and turnaround 

time, were the sample sets representative of 

real-world use in terms of infection 

prevalence, infection genotypes, and 

proportion of samples in window period? 

5b. For measures of diagnostic performance other 

than window period detection and turnaround 

time, was a reference standard with excellent 

accuracy used? If not, was a reference 

standard with very good accuracy used? 

5c. Were all consecutive patients enrolled (or a 

random sample of eligible patients)?

5d. Were readers of the diagnostic test of interest 

blinded to the results of the reference 

standard?

5e. Were readers of the reference standard 

blinded to the results of the diagnostic test of 

interest?

5f. Was the funding for this study derived from a 

source that would not benefit financially from 

either data favorable to the test or data 

unfavorable to the test?
14

Question Quality Criteria

6. Which donor interventions reduce the 

probability of pathogen transmission from an 

organ donor infected with HIV, HBV, or HCV 

to a previously uninfected recipient?

6a. Were the patients randomly assigned to 

treatments?

6b. Was the study planned prospectively 

(i.e., before any data were collected)

6c. Were all consecutive patients enrolled (or a 

random sample of eligible patients)?

6d. Were the two groups comparable at baseline? 

(age, sex, comorbidities, indication for 

transplant, previous duration on waitlist)

6e. If not, were statistical adjustments performed 

to control for baseline differences? 

6f. Were the two groups treated concurrently?

6g. Did at least 85% of the study enrollees 

provide data?

6h. Was the between-group difference in study 

completion rates less than 15%?

7. How do the clinical outcomes of recipients of 

organs from donors infected with HIV, HBV, or 

HCV compare to those who remain on the 

transplant list?

Same as Question 6

8. How do the clinical outcomes of transplant 

recipients who receive organs from donors 

with behavioral or nonbehavioral risk factors 

compare to those who remain on the 

transplant list?

Same as Question 6

9. What is the impact of excluding potential solid 

organ donors with behavioral or 

nonbehavioral risk factors on the organ donor 

pool?

Same as Question 6

10. What is the impact of false positive tests on 

the organ donor pool?

Same as Question 6
15

GRADE Assessment

We used the GRADE evidence rating methodology, which has been developed for treatment comparisons 

(Questions 6, 7 and 8)1 and diagnostics (Question 5).2 The GRADE system determines the quality of the 

evidence for a single outcome of a single comparison based on nine factors. “Quality” here encompasses 

not only quality in terms how well the study was designed, but also eight additional factors including 

inconsistency, indirectness, and imprecision of the evidence base (evidence base being all studies 

included for that outcome). The first factor (study design) sets the starting GRADE, in which randomized 

studies start at High, observational studies start at Low, and all other study designs start at Very Low. 

The next four factors can only be used to downgrade from this starting level (study quality limitations, 

inconsistency, indirectness, imprecision). The other four factors are grouped under “Other 

considerations”, and they are reporting bias (which can only be used to downgrade), large magnitude of 

effect, all plausible confounders would have reduced the effect, and dose-response association (these 

latter three factors can only be used to upgrade, if applicable). Ultimately, the GRADE system yields an 

overall rating for each outcome, which ranges from “very low” to “high”. The interpretation of these 

ratings is summarized in Table 6.

3 The details of the application of the GRADE system for each question 

are described in those sections.

Table 6. Interpretation of GRADE Ratings

Quality Rating Interpretation

High Further research is very unlikely to change our confidence in the estimate of 

effect

Moderate Further research is likely to have an important impact on our confidence in the

estimate of effect and may change the estimate

Low Further research is very likely to have an important impact on our confidence 

in the estimate of effect and is likely to change the estimate

Very Low Any estimate of effect is very uncertain

Note: These interpretations are from Box 2 of Guyatt et al. (2008).3

GRADE methodology has not been developed for the questions on epidemiology (Question 1), 

transmission (Question 2), risk factors (Questions 3 and 4), and the impact of exclusions on the donor 

pool (Questions 9 and 10). For these, we created GRADE methodology as follows. For Questions 1 and 2, 

no randomized trials are necessary to address the questions, therefore the starting evidence grade was 

High, and we applied the other components of the GRADE system as appropriate. For Questions 3 and 4, 

we used a starting evidence grade of Low because risk factor studies are by nature observational. Portions 

of Questions 3 and 4 involve the prevalence of risk factors; these were graded similarly as Question 1 

(epidemiology). For Questions 9 and 10, it was not necessary to develop new GRADE methodology, 

because for Question 9 there was only one study and it had already been graded in Question 8, and for 

Question 10 there were no included studies.
16

Statistical Analysis

To compute the 95% confidence interval around a single percentage, we used the Wilson score method.

4,5

For comparing pre-transplant characteristics, we computed the size of the between-group difference using 

Hedges’ g for continuous data and the difference in percentages for dichotomous data. We defined a large 

difference at baseline as a Hedges’ g of 0.4 or more for continuous data, or a difference in percentage of 

15 percentage points or more for dichotomous data. Where appropriate, we combined the results of 

multiple studies using DerSimonian and Laird random-effects meta-analysis6 using specialized software 

(Comprehensive Meta-Analysis, Biostat Inc., Englewood, New Jersey). We measured heterogeneity using 

the I2 statistic.7 For risk factors, we computed the odds ratio and/or relative risk (and 95% confidence 

intervals) using standard methods with a 0.5 continuity correction applied to studies with a 0% rate in 

either group. For diagnostics, we computed sensitivity and specificity (and 95% confidence intervals) 

using MetaDisc 1.4. Additional statistical methods are described for each question in the text for that 

question.

Evidence Tables

For each question, we constructed evidence tables displaying numerous details about each study. 

These varied by question, and included:

• Question 1 (epidemiology): Years of data collection, donor population, data sources, relevant viruses, 

diagnostic methods, whether diagnoses were confirmed, quality assessment criteria, and relevant data

• Question 2 (transmission): Country, specific transplantation centers, which organ(s), number of 

transplantation centers, study funding source, the use of pre-transplant prophylaxis, the frequency of 

post-transplant testing for infection, duration of follow-up, timing of post-transplant infections, 

diagnostic methods, pre-transplant patient characteristics, quality assessment criteria, which 

antigen/antibody was used for defining donor positivity, which antigen/antibody was used for defining 

recipient positivity after transplant, and the relevant data.

• Question 3 (behavioral risk factors): Virus(es), data source(s), country, selection methods, how risk 

factor data were collected, relevant blood tests used, study funding source, years of data collection, 

participant characteristics, specific risk factor(s) under investigation, specific population(s) included, 

how enrollees were selected, which confounders were adjusted for (if applicable), quality assessment 

criteria, reported statistical test results, and the relevant data

• Question 4 (nonbehavioral risk factors): Generally the same as in Question 3

• Question 5 (diagnostics): the index test and its category, data source(s), country, whether the 

infection status of samples was known before the study was conducted, whether the sample was 

unselected, the reference standard, other tests performed, test manufacturer, FDA approval date 

(if applicable), test format, whether specimens can be obtained from living donors or deceased donors 

or both, whether tests are applied to serum of plasma or both, quality assessment criteria, GRADE 

tables, reported data on diagnostic performance, window period, and turnaround time

• Question 6 (inactivation): all steps in the inactivation procedure, when the viral load was measured, 

quality assessment criteria, GRADE tables, the total viral burden before and after inactivation, the 

percentage of viral copies that had been removed
17

• Question 7 (clinical outcomes of known positive organs vs. waitlist or known negative organs):

Country, specific transplantation centers, which organ(s), number of transplantation centers, study 

funding source, pre-transplant patient characteristics, which antigen/antibody was used for defining 

donor positivity, diagnostic methods, quality assessment criteria, GRADE tables, whether “survival” 

meant graft survival or patient survival, duration of follow-up for each data point, any adjustments for 

confounding, reported statistical test results, and the relevant data

• Question 8 (clinical outcomes of at-risk organs vs. waitlist or not-at-risk organs): for models, 

key assumptions about donors/recipients/death rates/costs/QALYS, assumed incidence and prevalence 

in specific subpopulations, quality assessment criteria, GRADE tables, and relevant data

• Question 9 (impact of excluding donors with risk factors on the donor pool): Same as in Question 8

• Question 10 (impact of false positives on the donor pool): Same as in Question 8
18

Overview of the Evidence

A graphical depiction of the process of article identification appears in Figure 2. The three most common 

reasons for exclusion were: Not an empirical study (review, letter, commentary, etc.), did not address any 

questions for systematic review, and data on participants outside the U.S., and did not meet inclusion 

criteria for any of the questions that included non-U.S. data. Of the 167 included articles, the largest 

evidence bases were for Question 2 on transmission (60 articles) and Question 5 on diagnostic tests (45 

articles). The counts for other questions are shown in the figure.

For Question 5 (diagnostics), 99 items from the gray literature were reviewed for potentially useful data. 

These included literature from manufacturers’ Web sites (40), the internet (6), the Food and Drug 

Administration (FDA) (23), agencies in the United Kingdom (14), agencies from Australia (13), and 

items from the World Health Organization (3). We included data on window period or turnaround time 

from 26 of the 99 items.
19

Figure 2. Study Attrition Diagram

3,532 articles identified

167 articles met inclusion criteria

Articles 

reviewed

3,366 articles excluded:

1008 - Not an empirical study (review, letter, 

commentary, etc.)

667 - Did not address any questions for 

systematic review

494 - Data on participants outside the U.S., and 

did not meet inclusion criteria for any of the 

questions that included non-U.S. data

299 - Not a diagnostic test of interest

233 - Special population

113 - Did not report any outcomes of interest

84 - Used inactivation, but the target was not 

solid organs

80 - Fewer than five people enrolled

71 - Study of a pathogen or condition other 

than HIV/HBV/HCV

316 - Other

NOTE: The counts add to more than 166 because some articles were included for multiple questions.

Question 1 (epidemiology): 22 articles

Question 2 (transmission rate): 60 articles

Question 3 (behavioral risk factors): 22 articles

Question 4 (nonbehavioral risk factors): 29 articles

Question 5 (diagnostic tests): 45 articles

Question 6 (inactivation): 2 articles

Question 7 (clinical outcomes of organs from infected donors vs. waitlist or uninfected

 donors): 25 articles

Question 8 (clinical outcomes of organs from at-risk donors vs. waitlist or not-at-risk 

 donors): 2 articles

Question 9 (impact on pool of exclusion of those with risk factors): 1 article

Question 10 (impact on pool of exclusion of false positives): 0 articles
20

Evidence Reviews: I. Probability of transmission of HIV, HBV, or 

HCV through solid organ transplantation (SOT)

Question 1. What are the prevalence and incidence rates of HIV, HBV, 

and HCV among potential solid organ donors?

This question involves the frequency of HIV, HBV, and HCV among individuals whose organ(s) are 

being considered for donation. These rates may differ from rates in the general population or from the 

rates in individuals who actually did donate organ(s). We considered both the prevalence (the percentage 

of potential organ donors at a given time who test positive for the pathogen) as well as incidence (the 

percentage of potential organ donors who newly acquire the pathogen in a one-year period). 

Due to the small amount of evidence on potential solid organ donors, we expanded the scope to include 

other possibly relevant populations. Thus, the evidence for this question is described in separate sections:

1) Potential solid organ donors (three studies)

2) Actual solid organ donors who had donated prior to 1991 and their lab samples were 

retrospectively tested for HCV (four studies). Hepatitis C virus (HCV) was discovered in April of 

1989, and serological screening for it was not widely performed until 1991. Therefore, another 

possible source of epidemiological data is studies of stored blood or plasma samples from actual 

organ donors before 1991. Because of the early donation date, the samples had not been screened 

for HCV prior to donation.

3) Potential tissue donors (two studies). This population may be a reasonable approximation of

potential solid organ donors. 

4) The general population (six studies). This population may also approximate potential solid organ 

donors.

Potential Organ Donors

Three studies reported prevalence estimates of HIV, HCV, and/or HBV among potential organ donors. 

The definition of “potential organ donor” involved liver donor referrals in two studies (relatives wishing 

to donate to children,8,9 and deceased donors in the other studies.

10,11 Testing methods and diagnostic 

criteria were not consistently reported and may have varied among the studies. Differences in donor 

populations and methods used to diagnose and report infection probably contributed to the range in 

reported prevalence. It is not clear that the antibody tests were confirmed by a more specific method such 

as Western blot, recombinant immunoblot assay (RIBA), or nucleic acid-amplification tests (NAT) in 

most of these studies; lack of confirmation may have contributed to overestimation of prevalence due to 

antibody reaction false-positives. Lack of confirmation could also lead to an underestimation of 

prevalence if less sensitive antibody are used and if recent infections are missed. One study10 tested for 

HBV DNA among those whose serological tests was equivocal or positive for antibodies for the core 

antigen (anti-HBc) or the surface antigen (HBsAg).

In the study that reported it, the prevalence of HCV was 3.6% among potential living donor relatives.8

The prevalence of active hepatitis, type unspecified, among deceased potential donors rejected from 
21

donation was reported as 5.3% (95% CI: 2.2% to 12.2%) in a study of potential deceased donors.11 The 

remaining study reported the prevalence of unspecified hepatitis at 18.2% (95% CI: 7.0% to 39.6%)

among potential living donor relatives excluded at the second stage of evaluation.

9

HIV prevalence was also reported by two of those studies. A study of living adult potential donors did not 

detect any cases of HIV out of the 45 individuals screened9,9, and the study on potential deceased donors 

reported the prevalence of HIV or syphilis (data for HIV alone not reported) at 2.1% (95% CI: 0.5% to 

8.1%).11

The quality assessment items are listed in Table 13. Meta-analysis was not performed because there were 

no instances where at least two studies reported the prevalence of the same virus. These data and 

additional information regarding the studies they were extracted from are shown in Table 7, below.
22

Table 7. Prevalence of Hepatitis and HIV among Potential Organ Donors

Citation Year

Year of 

Data 

Collection

Donor 

Population

Data 

Collection Virus

Diagnostic 

Method Confirmed? Prevalence

Hepatitis

Hidalgo et al.8 2001 1990 to 

1999

Living adult

parents

Retrospective 

chart review

HCV Not reported Not reported 3.6%

(95% CI: 1% to 12.3%)¶

(2/55)

Domen et al.10 2000 10/94 to 

10/98

Potential organ 

donors

Retrospective 

chart review

HBV Unspecified 

serology

HBV-DNA was 

also tested in 

16 of 22, and it 

was positive in 

1/16.

4.9%*

(95% CI: 3.3% to 

7.4%)¶

(22/446)

Renz et al.9 1995 5/1992 to 

5/1994

Living adult 

relatives

Retrospective 

review

Hepatitis 

(both B and 

C were 

screened for)

Unspecified 

serology

Not reported 18.2%

(95% CI: 7.0% to 

39.6%)

(4/22) ¶

Richards11 1993 9/1989 to 

8/1991

Deceased 

donors; 

potential 

cardiac donors

Retrospective 

data review

Active viral 

hepatitis 

(Authors did 

not report 

how many of 

the 430 

potential 

donors had 

been tested

for hepatitis.)

Not reported Not reported Of the 94 potential 

donors excluded from 

donation for medical 

reasons, 5.3%; 

95% CI: 2.2% to 

12.2%)¶ were excluded 

due to active hepatitis.

HIV

Renz et al.9 1995 5/1992 to 

5/1994

Living adult 

relatives

Retrospective 

review

HIV Unspecified 

serology

Not reported 

(no positives)

0%

(95% CI: 0% to 100%)

(0/22) **¶
23

Citation Year

Year of 

Data 

Collection

Donor 

Population

Data 

Collection Virus

Diagnostic 

Method Confirmed? Prevalence

Richards11 1993 9/1989 to 

8/1991

Potential 

deceased 

cardiac donors

Retrospective 

data review

HIV or 

syphilis 

(not reported 

separately). 

Authors did 

not report 

how many of 

the 430 

potential 

donors had 

been tested

for HIV.

Not reported Not reported Of the 94 potential 

donors excluded from 

donation for medical 

reasons, 2.1%; 

95% CI: 0.5% to 8.1%)¶

were excluded due to 

HIV or syphilis.

* Domen et al.10 included those with equivocal tests as well as those with positive tests, but did not report the corresponding counts.

95% confidence interval (CI) calculated by ECRI Institute.

¶ **The denominator of 22 is the number of candidates who underwent phase 2 of evaluation for donation, out of 75 total considered for evaluation.
24

Pre-1991 Organ Donors Retrospectively Tested for HCV

We included four such studies, the methods and results are shown in Table 8. All four studies met two of the three quality criteria (not selecting 

patients on the basis of behavioral or demographic factors, and using a standardized diagnostic test for determining infection status). Two studies 

only included deceased donors, and the other two did not report whether donors were living. The studies found a wide range of prevalence from 

2.4% to 6.8%. Because the studies’ methods were sufficiently similar, we combined the results in a random-effects meta-analysis, and this 

revealed substantial heterogeneity (I2 = 85%); the combined estimate of HCV prevalence was 4.0% (95% CI: 2.2% to 7.3%).

These rates may be influenced by geography as well as the specific anti-HCV tests used by investigators. Shah et al. (1993)12 collected data from 

those who had received transplants in Pittsburgh, and they used a second generation ELISA assay (no further specifics reported). Vincenti et al. 

(1993)13 assessed organ donors from California and tested samples for anti-HCV using an ELISA but did not report the generation, and also tested 

for HCV RNA. Pereira et al. (1992)14 assessed organ donors from New England using a second generation ELISA assay (the HCV Elisa 2.0 Test 

System from Ortho Diagnostics) that "detects antibody to four recombinant HCV antigens (5-1-1, c100, c33, and c22)", the RIBA HCV Test 

system from Chiron, and test for HCV RNA using PCR.14 Roth et al. (1992)15 assessed organ donors from Miami "using a commercial ELISA 

(Ortho Diagnostic Systems)" (unreported generation), "a second generation RIBA" (Chiron Corporation)", and test for HCV RNA via PCR.

15

Table 8. Prevalence of HCV among Pre-1991 Organ Donors

Citation

Dates of 

Organ Donation Donor Population Data Collection Diagnostic Method Confirmed? Prevalence

Shah et al. 

(1993)12,16

Mar-86 to Mar-90 Liver donors

(unreported whether 

living or deceased)

Retrospective

testing of 

lab samples

Anti-HCV by ELISA2 Not reported 5.8%

(95% CI: 4.1% to 8.2%)

(30/516) ¶

Vincenti et al. 

(1993)13

Jan-86 to Dec-88 Deceased kidney 

donors

Retrospective

testing of 

lab samples

Anti-HCV by ELISA 

(unreported version)

Yes, all four positives 

were confirmed as

HCV RNA+

2.8%

(95% CI: 1.1% to 7.0%)

(4/143) ¶

Pereira et al. 

(1992)14,17-19

1985 to 1992 Deceased organ 

donors

Retrospective

testing of 

lab samples

Anti-HCV by ELISA1 

and ELISA2

Of those positive by 

ELISA1, 47% were 

positive for HCVRNA.

2.4%

(95% CI: 1.9% to 3.0%)

(73/3078)

a

¶

Roth et al. 

(1992)15,20

Jan-79 to Feb-91 Deceased organ 

donors

Retrospective

testing of 

lab samples

ELISA (unreported 

version) and RIBA

Half of the RIBA+ 

donors were 

HCV RNA+

6.8%

(95% CI: 4.9% to 9.4%)

(33/484) ¶
25

Citation

Dates of 

Organ Donation Donor Population Data Collection Diagnostic Method Confirmed? Prevalence

Combined prevalence (random-effects meta-analysis; I2 = 85%) 4.2%

(2.2% to 7.7%)

¶ 95% confidence interval (CI) calculated by ECRI Institute.

a The prevalence in the Pereira et al. study was based on the largest publication, which included 3078 tested donors.17 The number in the table is the study’s 

estimated prevalence of positivity for HCV RNA, based on the two findings that 5.1% of the 3078 donors were ELISA1 positive, and 47% of those were HCV 

RNA positive (i.e., 47% of 5.1% is 2.4%)
26

Potential Tissue Donors

We included one retrospective study on this population. Zou et al. assessed the frequency of HBV, HCV, 

and/or HIV among tissue donors and estimated both incidence and prevalence.

21 Four of the 5 tissue 

centers in Zou et al. reported confirmed positive results whereas one center reported screening results 

only. Zou et al. estimated confirmed positive results for the fourth center using data from the other sites.

Table 9 shows the pertinent data. The prevalence of confirmed HIV was 0.093% (95% CI 0.036% to

0.150%) of donors.. The prevalence of confirmed HBV was 0.229% (95% CI 0.139% to 0.319%) among 

donors in Zou et al. Zou et al. also used the tissue donor data as well as blood donor data to estimate the 

incidence of early viral infection undetected during the serologic window period. Their estimated 

incidence rates per 100,000 person years were 30.11 for anti-HIV, 18.325 for HbsAg, and 12.380 for antiHCV.
27

Table 9. Prevalence of Hepatitis and HIV Among Potential Tissue Donors

Citation Year

Year of Data 

Collection

Donor 

Population

Data 

Collection Virus

Diagnostic 

Method Confirmed? Prevalence*

Hepatitis

Zou et al.21 2004 2000 

through 

2002

Tissue 

donors, 

no other 

information 

provided

Prevalence 

data 

retrospectively 

collected from 

tissue bank 

databases of 

5 tissue banks; 

Incidence 

estimated

HBV HbsAg Yes 0.229%

(95% CI: 0.139% to 0.319%)¶

HCV Anti-HCV Yes 1.091%

(95% CI: 0.896% to 1.286%)¶

HIV

Zou et al.21 2004 2000 

through 

2002

Tissue 

donors, 

no other 

information 

provided

Prevalence 

data 

retrospectively 

collected from 

tissue bank 

databases of 

5 tissue banks; 

Incidence 

estimated

HIV Anti-HIV Yes 0.093%

(95% CI: 0.036% to 0.150%)¶

* Denominator represents all potential donors who were tested for HIV, HBV and HCV.

¶ 95% confidence interval (CI) calculated by ECRI Institute.
28

General Population

The six included general population studies are listed in Table 10. All six studies met two of the three 

quality criteria (not selecting patients on the basis of behavioral or demographic factors, and using a 

standardized diagnostic test for determining infection status).

For HIV in the general population, the CDC has estimated that the annual U.S. incidence in 2006 was 

56,30022,23 and the prevalence was 1,106,400.24 The U.S. population was approximately 299,000,000 in 

that year,25 thus the incidence was approximately 0.019% (1 in 5,308) and the prevalence was 

approximately 0.37% (1 in 270).

For HBV and HCV in the general population, Table 11 provides the most recently available estimates.

The U.S. population was approximately 302,000,000 in 2007,25, which means the incidence rates for 

HBV and HCV were 0.014% (1 in 7,023) and 0.0056% (1 in 17,765), respectively. These data are based 

on estimates from multiple sources including the National Health and Nutrition Examination Survey 

(NHANES), the National Notifiable Diseases Surveillance System (NNDSS), the Emerging Infection 

Program, and the American Community Survey.

Table 10. Methods of Studies Included on Incidence and Prevalence in the 

U.S. General Population

Citation

Year of 

Data 

Collection Data Collection Virus(es)

Diagnostic 

Method* Confirmed?

Hepatitis

Daniels et al. 

(2009)26,27

2007 NNDSS HBV, HCV Various; 

specifics not 

reported

Yes

Weinbaum et al. 

(2008)28

2006 NHANES, ACS HBV Not reported NR

McQuillan et al. 

(1999)29

1988-1994 NHANES HBV Not reported NR

Armstrong et al. 

(2006)30

1999-2002 NHANES HCV 3rd generation 

ELISA

Yes, using 

RIBA or 

HCV-RNA test

HIV

Prejean et al. 

(2009)

22,23

2006 A new national 

case reporting 

system 

HIV STARHS NR

Centers for 

Disease Control

(2008)24

2006 A new national 

case reporting 

system

HIV STARHS NR

* ACS – American Community Survey

ELISA – Enzyme-linked immunosorbent assay

NHANES – National Health and Nutrition Examination Survey

NNDSS – National Notifiable Disease Surveillance System

STARHS – Serological testing algorithm for recent HIV seroconversion
29

Table 11. Incidence and Prevalence of HBV and HCV in the U.S. General Population

HBV HCV

Incidence 43,000 (in 2007)

26,27 17,000 (in 2007)26,27

Number of acute clinical casesa 13,000 (in 2007)

26,27 2,800 (in 2007)26,27

Number of people with chronic 

infectionb

Between 0.8 million and 

1.4 million (in 2006)

28

Between 2.7 million and 

3.9 million (in 1999-2002)30

Percentage of people ever infectedc Between 4.3% and 5.6%

(in 1988-1994)29

Between 1.3 and 1.9%

(in 1999-2002)30

a

For hepatitis B, the incidence estimates and the estimated number of acute clinical cases are “derived from catalytic 

modeling of seroprevalence data from the Third National Health and Nutrition Examination Survey (NHANES III) 

applied to cases reported to the National Notifiable Diseases Surveillance System (NNDSS).”

27 For hepatitis C in 

2007, these estimates were based on data from the Emerging Infection Program.27 The number of acute clinical 

cases is different from incidence, because most new infections are asymptomatic (and thus not diagnosed or 

reported).. b

For hepatitis B, the number of people with chronic infection was based on the 2006 American Community Survey 

and a U.S. Department of Justice study of prison and jail inmates.

28 For hepatitis C, the numbers were based on

NHANES data from 1999-2002.

30

c

For hepatitis B, the percentage of people ever infected was based on NHANES data from 1988-1994.29

For hepatitis C, the numbers were based on NHANES data from 1999-2002.30

GRADE Assessment of Epidemiology

The GRADE table for this question appears in Table 12. We graded the evidence as Low for all three 

pathogens. This was due to two concerns: varying estimates of epidemiological statistics, and the use of 

populations other than potential organ donors. The variation in estimates between the different studies 

was not simply due to their enrollment of different populations. For example, even within the four studies 

of pre-1991 actual organ donors who were retrospectively tested for HCV, prevalence estimates ranged 

widely (by a factor of more than three: from 1 in 15 to 1 in 55).
30

Table 12. GRADE Table for Question 1 (Epidemiology) Pathogen

Outcome

Quantity and 

Type of Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Base

-response

Confounders would reduce the effect

HIV Incidence 1 study of potential 

tissue donors21

1 study of the U.S. 

general population22,23

In the study of potential tissue

donors, incidence of 30.11 per 

100,000 person-years

In the general population 

study, incidence of 56,300 in 

2006, which corresponds to 

18.8 per 100,000 person years

High 0 -1 -1 0 0 0 0 0 Low

Prevalence 2 studies of potential 

organ donors9,11

1 study of potential 

tissue donors21

1 study of the U.S. 

general population24

In the studies of tested 

potential organ donors, 

prevalence of HIV was 

0/22 (0%), and prevalence of 

HIV or syphilis was and 

2/94 (2.1% or 1 in 48).

In the study of potential tissue

donors, prevalence was 

10/10,910 (0.093% or 

1 in 1,090).

In the general population 

study, prevalence was 

1,106,400 in 2006 (0.37%, or 

1 in 270)

High 0 -1 -1 0 0 0 0 0 Low Low
31

Pathogen

Outcome

Quantity and 

Type of Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Base

-response

Confounders would reduce the effect

HBV Incidence 1 study of potential 

tissue donors21

1 study of the U.S. 

general population26,27

In the study of potential tissue

donors, incidence of 18.325 

per 100,000 person-years

In the general population 

study, 43,000 incidence in 

2007, which corresponds to 

14.4 per 100,000 person-years

High 0 0 -1 0 0 0 0 0 Moderate

Prevalence 1 study of HBV in 

potential organ donors10

2 studies of 

hepatitis(including HBV 

and HCV) in tested 

potential organ 

donors9,11

1 study of potential 

tissue donors21

1 study of the U.S. 

general population28

In the study of HBV in potential 

organ donors, prevalence was 

22/446 (4.9%, or 1 in 20).

In the two studies of hepatitis

in potential organ donors,

prevalence of 5/94 (5.3%, or 1 

in 19) and4/22 (18.2%, or 1 in 

6).

The study of potential tissue 

donors reported a prevalence 

of 25/10901 (0.229%, or 1 in 

436)..

In the general population 

study, prevalence of chronic 

infection was 1.1 million in 

2006 (0.36% or 1 in 274)

High 0 -1 -1 0 0 0 0 0 Low Low
32

Pathogen

Outcome

Quantity and 

Type of Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE of 

Evidence for 

Outcome

Overall 

GRADE of 

Evidence 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Base

-response

Confounders would reduce the effect

HCV Incidence 1 study of potential 

tissue donors21

1 study of the U.S. 

general population26,27

In the study of potential tissue

donors, incidence of 12.38 per 

100,000 person-years

In the general population 

study, 17,000 incidence in 

2007, which corresponds to 5.7 

per 100,000 person-years

High 0 -1 -1 0 0 0 0 0 Low

Prevalence 1 study of HCV in 

potential organ donors8

1 study of “hepatitis” in 

potential organ donors9

4 studies of prevalence 

among pre-1991 organ 

donors12-18,20

1 study of potential 

tissue donors21

1 study of the U.S. 

general population30

In the study of HCV in potential 

organ donors, prevalence was 

2/55 (3.6%, or 1 in 28).

In the study of HBV and HCV

in potential organ donors, 

prevalence was 5/430 (1.2%, 

or 1 in 86)

In the studies of pre-1991 

organ donors, combined 

estimate of prevalence of 4.0% 

or 1 in 25.

In the study of potential tissue 

donors, prevalence of 

119/10915 (1.091%, or 1 in 

92).

In the general population 

study, prevalence of chronic 

infection was 3.3 million in 

1999-2002 (1.1 % or 1 in 86)

High 0 -1 -1 0 0 0 0 0 Low Low
33

Additional Evidence Tables for Question 1

Table 13. Question 1: Quality Assessment

Study 1a 1b 1c

Potential Solid Organ Donors

Hidalgo et al.(2001)8  

Domen et al.(2000)10   

Renz et al. (1995)9  

Richards (1993)11  

Actual Solid Organ Donors Pre-1991 Retrospectively Tested for HCV

Shah et al. (1993)12,16  

Vincenti et al. (1993)13  

Pereira et al. (1992)14,17-19  

Roth et al. (1992)15,20  

Potential Tissue Donors

Zou et al. (2004)21  

General Population

Daniels et al. (2009)26,27  

Weinbaum et al. (2008)28  

McQuillan et al. (1999)29  

Armstrong et al. (2006)30  

Prejean et al. (2009)

22,23  

Centers for Disease Control (2008)24  

A checkmark () means that the study met the quality criterion for this Question; the lack of a checkmark means that 

the study either did not meet the criterion, or it was unclear whether the study met the criterion. The criteria specific to 

this Question were: 

1a. Was the population potential solid organ donors?

1b. For other populations, was the population unselected (i.e., not based on demographic or behavioral 

characteristics)? (Studies of potential solid organ donors were scored as Yes, because they enrolled the 

population of interest.)

1c. Was infection status determined accurately? (i.e., accuracy of diagnostic test method used to determine 

infection status)
34

Question 2. What are the rates of transmission to recipients from donors 

infected with HIV, HBV, or HCV? Do the rates vary by the organ 

transplanted or when the donor was infected?

For this question, the rate of transmission is the chance that an infected organ donor transmits the 

infection to a previously uninfected recipient. The observed rate of transmission likely depends on 

numerous factors, including the bloodborne pathogen (HIV, HBV, or HCV), the organ transplanted, the 

specific antigens or antibodies for which the donor was positive, whether HBV prophylaxis was used, and 

the type of serologic testing used for detection. Thus, as we tabulated information from the large evidence 

base for this question, we carefully delineated those facets that could potentially influence the results.

Sixty articles met the inclusion criteria. These contained some duplication of patients, and after careful 

perusal, the evidence comprised 44 unique studies (a single “study” can involve multiple publications 

from the same center on the same kinds of patients who were enrolled in overlapping timeframes). All 

studies addressed either HBV or HCV, and we extracted data on those recipients who were negative 

before transplant and who had received organs from donors who had tested positive. The lack of evidence 

on HIV is probably a result of federal regulations that prohibit transplantation of organs from individuals 

known to be HIV-positive.

The evidence for this question is considered in seven separate sections, according to different pathogens 

and organs:

- 16 studies of HBV transmission from liver transplantation

- 9 studies of HBV transmission from kidney transplantation

- 6 studies of HBV transmission from heart transplantation

- 1 study of HBV transmission from lung transplantation

- 2 studies of HCV transmission from liver transplantation

- 10 studies of HCV transmission from kidney transplantation

- 4 studies of HCV transmission from heart transplantation

Reported results on transmission can vary greatly based on numerous factors. Obviously, the specific 

pathogen and the specific organ are critical factors. Also, the type of serological testing will matter, 

specifically 1) For which antigen/antibody was the donor positive? and 2) For which antigen/antibody 

was the recipient tested? One study might include organ donors who were anti-HBc+ and HBsAg-, and 

report the rate of HBsAg positivity among recipients. Another study might include the same types of 

donors, but report the rate of positive HBV DNA in serum among recipients. These studies are detecting 

infection in different ways, therefore it would not make sense to consider their results together. Still other 

important factors include the use of prophylaxis (e.g., lamivudine), specific diagnostic tests used, the 

frequency and timing of these tests, and the length of follow-up after transplantation. In our presentation 

of the evidence, we provide information about these factors to aid interpretation of results.

General characteristics of the 44 included studies are listed in Table 22 and Table 23. Twenty-six studies

were conducted in the U.S., with the remaining 17 studies conducted in Spain (four studies), Japan (three 
35

studies), Italy (three studies), France (two studies), Latvia, Belgium, Germany, Taiwan, Canada, and the 

U.K. (one study each). Thirty-five studies were conducted at only a single center. Data were collected 

retrospectively in 35 studies, prospectively in seven studies, and not reported in the other two studies. 

Consecutive enrollment was performed in 26 studies. The pre-transplant patient characteristics are listed 

in Table 24, quality assessments appear in Table 25, and the reported results are listed in Table 26.

A plot of the transplantation dates appears in Figure 3 below. The start dates of organ transplantations

ranged from January 1979 to April 2001, with the median at June 1994. The end dates ranged from 

December 1988 to June 2004, with the median at July 1999. The median length of the transplantation

period (the period of time when data were collected) was 4.4 years, with a range from 1.7 to 15.7.

Only 13 studies reported information about study funding. These generally involved national funding 

sources, not corporations with conflicts of interest. The mean or median length of follow-up was reported 

by 26 studies, and it ranged from five months to 5.25 years, with a median of two years.
36

Figure 3. Question 2: Plot of Transplantation Dates

1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999 2001 2003 2005

Studies investigating rate of HBV transmission

Veroux (2005)

Hartwig (2005)

Tenderich (2005)

Fabrega (2003)

Miedouge (2003)

Loss (2003)

Suehiro (2005)

Pinney (2005)

Holt (2002)

Nery (2003)

Roque-Afonso (2002)

De Feo (2005)

Yu (2001)

Donataccio (2006)

Dodson (1999)

Castells (2002)

Blanes (2002)

Preito (2001)

Fong (2002)

Ko (2001)

Madayag (1997)

Montalti (2004)

Uemoto (1998)

Satterthwaite (1997)

Dickson (1997)

Kadian (1994)

Wachs (1995)

Rozental (2002)

Abbott (2004)

Marelli (2002)

Gudmundsson (2003)

Haji (2004)

File (2003)

Everhart (1999)

Tesi (1994)

Mendez (1993)

Tokumoto (1996)

Pereira (1992)

Preiksaitis (1997)

Shah (1993)

Wreghitt (1994)

Vincenti (1993)

Roth (1992)

Range of dates of transplantation

Studies investigating rate of HCV transmission
37

Thus, the “typical” study for Question 2 was a single-center U.S. study of unknown funding source that 

collected data retrospectively on consecutive patients who received an organ transplant in a four-year 

period in the mid-late 1990’s, and were followed for an average of two years.

Pre-transplant characteristics of donors and recipients are listed in Table 24. Most studies (30 of 44, or 

68%) did not report any characteristics specifically for those donor-recipient pairs in which the donor was 

positive and the recipient was negative before transplant. For the 13 studies that did report these 

characteristics, the following characteristics were reported by three or more studies:

• The mean donor age ranged from 39 to 43 (in the three studies reporting donor age)

• The mean recipient age ranged from 33 to 57 (nine studies)

• The percentage of males among donors ranged from 42% to 74% (three studies)

• The percentage of males among recipients ranged from 33% to 90% (ten studies)

• The percentage or recipients who were UNOS Status 1 ranged from 56% to 100% (three studies; 

these were studies of HCV transmission after heart transplantation)

Regarding quality assessment (Table 25), 37 of 44 studies (84%) were retrospective, and 26 of 44 studies

(59%) enrolled patients consecutively. Twelve of 44 studies (27%) used some form of prophylaxis 

(e.g., HBIg, lamivudine) for all recipients, six used it for some but not all recipients, two used it for no 

recipients, and the other 23 studies did not report whether prophylaxis had been used. The frequency of 

post-transplant serology testing was reported by 21 studies, and the methods varied widely:

• Seven studies performed relatively intensive monitoring for hepatitis (e.g., “at weeks 1, 2, 3, 4, 

then monthly for one year, then every three months.”)

31

• Four studies performed relatively moderate monitoring (e.g., “At months 1, 3, and 6, then yearly”)

32

• Six studies used only sporadic monitoring. (e.g., “When possible, samples were obtained at 

4 months, one year, and two years after transplant”)

33

• Three studies reported regular monitoring without stating a frequency (e.g., each patient was 

“tested on one or more occasions during routine clinical visits”)

34

• One study reported the use of liver biopsy “when clinically indicated”

35

The next seven subsections describe the study results for this question.

HBV Transmission from Liver Transplantation

Studies measured virus transmission in 14 different ways for the transmission of HBV from liver 

transplantation (Table 14). As shown in the next to rightmost column, the range of rates was very wide.

The results are shown graphically in Figure 4 and Figure 5. One possible explanation for the differences 

among studies is the use of prophylaxis, which may result in negative recipient testing despite potential 

transmission. Studies that used HBV prophylaxis for all patients are depicted with open circles; studies 

that used HBV prophylaxis for some but not all patients are depicted with gray circles; studies that used 

HBV prophylaxis for no patients are depicted with black circles; studies that did not report whether 
38

patients received prophylaxis are depicted with X’s. The graphs suggest that rates were lower when 

prophylaxis was used.

Table 14. LIVER Transplantation: Ranges of HBV Results

Donor was:

Recipient was tested 

for post-transplant 

positivity of:

# of 

Studies

Range of 

Results Studies

Anti-HBc+ HBsAg 5 0% to 94% Roque-Afonso et al. (2002)36, 

Yu et al. (2001)35, 

Dodson et al. (1999)37, 

Uemoto et al. (1998)38-41, 

Kadian et al. (1994)42

Anti-HBc+ HBeAg 2 40% to 94% Uemoto et al. (1998)38-41, 

Kadian et al. (1994)42

Anti-HBc+ anti-HBs 2 0% to 44% Roque-Afonso et al. (2002)36, 

Yu et al. (2001)35

Anti-HBc+ anti-HBc 2 0% to 78% Roque-Afonso et al. (2002)36, 

Yu et al. (2001)35

Anti-HBc+ serum HBV-DNA 2 40% to 94% Uemoto et al. (1998)38-41, 

Kadian et al. (1994)42

Anti-HBc+ “Developed de novo 

infection”

1 6% Montalti (2004)43

Anti-HBc+ and 

HBsAgHBsAg 9 0% to 78% De Feo et al. (2005)44,45, Holt et al. (2002)46, 

Donataccio et al. (2006)47, 

Suehiro et al. (2005)48, 

Fabrega et al. (2003)49, 

Nery et al. (2003)50, 

Preito et al. (2001)32, 

Dickson et al. (1997)33, 

Wachs et al. (1995)51

Anti-HBc+ and 

HBsAgHBeAg 2 13% to 67% Nery et al. (2003)50, Preito et al. (2001)32

Anti-HBc+ and 

HBsAganti-HBs 2 0% to 5% Castells et al. (2002)52, Wachs et al. (1995)51

Anti-HBc+ and 

HBsAganti-HBc 3 0% to 37% Holt et al. (2002)46, Donataccio et al. (2006)47, 

Castells et al. (2002)52

Anti-HBc+ and 

HBsAgliver HBV-DNA 2 0% to 13% Holt et al. (2002)46, Nery et al. (2003)50

Anti-HBc+ and 

HBsAgserum HBV-DNA 7 0% to 71% Holt et al. (2002)46, Suehiro et al. (2005)48, Fabrega et al. 

(2003)49, Loss et al. 

(2003)31,53, 

Nery et al. (2003)50, 

Castells et al. (2002)52, 

Preito et al. (2001)32
39

Donor was:

Recipient was tested 

for post-transplant 

positivity of:

# of 

Studies

Range of 

Results Studies

Anti-HBc+ and 

HBsAglymphocytes HBV-DNA 1 0% Fabrega et al. (2003)49
40

Figure 4. LIVER Transplantation: HBV Positivity in Recipients After the Use of

Anti-HBc+ Donors

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Transmission rate

DONOR

was:

RECIPIENT was 

post-transplant

positive for:

HBsAg

serum HBV

anti-HBc

anti-HBs

HBeAg

"Developed de

novo infection"

LIVER TRANSPLANT

anti-HBc+

Note: This figure displays the reported rates of positivivity among pre-transplant negative recipients after receiving 

organs from positive donors.. The title of the figure indicates the relevant pathogen(s) and organ(s). These 

data also appear in Table 26. The definitions of donor positivity appear on the left side of the figure, and the 

definitions of recipient post-transplant positivity appear on the right side of the figure. White circles indicate 

studies where all recipients received prophylaxis; gray circles indicate studies where some but not all 

recipients received prophylaxis; black circles indicate studies where none of the recipients received 

prophylaxis; an X indicates studies that did not report whether prophylaxis was used.
41

Figure 5. LIVER Transplantation: HBV Positivity in Recipients After the Use of Organs

from Anti-HBc+ HbsAg- Donors

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Transmission rate

HBsAg

serum HBV DNA

anti-HBc

anti-HBs

HBeAg

lymphocytes HBV DNA

liver HBV DNA

LIVER TRANSPLANT

anti-HBc+

HBsAgDONOR

was:

RECIPIENT was 

post-transplant

positive for:

Note: This figure displays the reported rates of positivivity among pre-transplant negative recipients after receiving 

organs from positive donors. The title of the figure indicates the relevant pathogen(s) and organ(s). These data 

also appear in Table 26. The definitions of donor positivity appear on the left side of the figure, and the 

definitions of recipient post-transplant positivity appear on the right side of the figure. White circles indicate 

studies where all recipients received prophylaxis; gray circles indicate studies where some but not all 

recipients received prophylaxis; black circles indicate studies where none of the recipients received 

prophylaxis; an X indicates studies that did not report whether prophylaxis was used.
42

HBV Transmission from Kidney Transplantation

Studies measured virus transmission in 13 different ways for the transmission of HBV from kidney

transplantation (Table 15). These rates were very low. The reported resultsare shown graphically in

Figure 6 and the top section of Figure 7.

Table 15. KIDNEY Transplantation: Ranges of HBV Results

Donor was:

Recipient was tested 

for post-transplant 

positivity of:

# of 

Studies

Range of 

Results Studies

anti-HBc+ HBsAg 1 0% Kadian et al. (1994)42

anti-HBc+ HBeAg 1 0% Kadian et al. (1994)42

anti-HBc+ anti-HBs 1 0% Kadian et al. (1994)42

anti-HBc+ anti-HBc 1 0% Kadian et al. (1994)42

anti-HBc+ serum HBV-DNA 1 0% Kadian et al. (1994)42

HBsAg-, 

anti-HBc+

HBsAg 6 0% De Feo et al. (2005)44,45, 

Veroux et al. (2005)54, 

Fong et al. (2002)55, 

Madayag et al. (1997)56, 

Satterthwaite et al. (1997)57, 

Wachs et al. (1995)51

HBsAg-, 

anti-HBc+

anti-HBs 4 0% to 11% Akalin et al. (2005)58, 

Madayag et al. (1997)56, 

Satterthwaite et al. (1997)57, 

Wachs et al. (1995)51

HBsAg-, 

anti-HBc+

anti-HBc 7 0% to 13% De Feo et al. (2005)44,45, 

Akalin et al. (2005)58, 

Veroux et al. (2005)54, 

Fong et al. (2002)55, 

Madayag et al. (1997)56, 

Satterthwaite et al. (1997)57, 

Wachs et al. (1995)51

HBsAg-, 

anti-HBc+

anti-HBs and anti-HBc 1 0% Satterthwaite et al. (1997)57

HBsAg-, 

anti-HBc+

“HBV viremia” 1 0% Akalin et al. (2005)58

HBsAg-, 

anti-HBc+, 

serum HBV-DNAHBsAg 1 0% Miedouge et al. (2003)59

HBsAg-, 

anti-HBc+, 

serum HBV-DNAanti-HBc 1 0% Miedouge et al. (2003)59

HBsAg-, 

anti-HBc+, 

serum HBV-DNAserum HBV-DNA 1 0% Miedouge et al. (2003)59
43

Figure 6. KIDNEY Transplantation: HBV Positivity in Recipients After the Use of

Organs from Anti-HBc+ Donors or Anti-HBc+ HbsAg- Donors

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Transmission rate

HBsAg

serum HBV DNA

anti-HBc

anti-HBs

HBeAg

anti-HBc+

anti-HBc+

HBsAgHBsAg

anti-HBs

anti-HBc

KIDNEY TRANSPLANT

DONOR

was:

RECIPIENT was 

post-transplant

positive for:

Note: This figure displays the reported rates of positivivity among pre-transplant negative recipients after receiving 

organs from positive donors. The title of the figure indicates the relevant pathogen(s) and organ(s). These data 

also appear in Table 26. The definitions of donor positivity appear on the left side of the figure, and the 

definitions of recipient post-transplant positivity appear on the right side of the figure. White circles indicate 

studies where all recipients received prophylaxis; gray circles indicate studies where some but not all 

recipients received prophylaxis; black circles indicate studies where none of the recipients received 

prophylaxis; an X indicates studies that did not report whether prophylaxis was used.
44

Figure 7. Other Results for HBV

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Transmission rate

HBsAg

serum HBV DNA

anti-HBc

anti-HBs or anti-HBc

KIDNEY TRANSPLANT

anti-HBc+

HBsAganti-HBc+

HBsAgserum HBV-

"HBV viremia"

LUNG TRANSPLANT

HEART TRANSPLANT

anti-HBc+

HBsAg

anti-HBs

anti-HBc

anti-HBc+,HBsAganti-HBs+

anti-HBc+

HBsAgserum HBVHBsAg

serum HBV DNA

lymphocyte HBV DNA

anti-HBc+

HBsAgHBsAg

anti-HBc

DONOR

was:

RECIPIENT was 

post-transplant

positive for:

anti-HBc+,HBsAgHBsAg

Note: This figure displays the reported rates of positivivity among pre-transplant negative recipients after receiving 

organs from positive donors. The title of the figure indicates the relevant pathogen(s) and organ(s). These data 

also appear in Table 26. The definitions of donor positivity appear on the left side of the figure, and the 

definitions of recipient post-transplant positivity appear on the right side of the figure. White circles indicate 

studies where all recipients received prophylaxis; gray circles indicate studies where some but not all 

recipients received prophylaxis; black circles indicate studies where none of the recipients received 

prophylaxis; an X indicates studies that did not report whether prophylaxis was used.
45

HBV Transmission from Heart Transplantation

Studies measured virus transmission in nine different ways for the transmission of HBV from heart 

transplantation (Table 16). The reported results are shown graphically in the middle section of Figure 7

above.

Table 16. HEART Transplantation: Ranges of HBV Results

Donor was:

Recipient was tested 

for post-transplant 

positivity of:

# of 

Studies

Range of 

Results Studies

anti-HBc+ HBsAg 1 0% to 4% Pinney et al. (2005)60, 

Kadian et al. (1994)42

anti-HBc+ anti-HBs 3 8% to 48% Pinney et al. (2005)60, 

Tenderich et al. (2005)61, 

Kadian et al. (1994)42

anti-HBc+ anti-HBc 2 18% to 65% Tenderich et al. (2005)61, 

Kadian et al. (1994)42

HBsAg-, 

anti-HBc+

HBsAg 1 0% De Feo et al. (2005)44,45

HBsAg-, 

anti-HBc+, 

anti-HBs+

HBsAg 1 0% Ko et al. (2001)62,63

HBsAg-, 

anti-HBc+, 

serum HBV-DNAHBsAg 1 0% Blanes et al. (2002)64

HBsAg-, 

anti-HBc+, 

serum HBV-DNAanti-HBc 1 0% Blanes et al. (2002)64

HBsAg-, 

anti-HBc+, 

serum HBV-DNAserum HBV-DNA 1 0% Blanes et al. (2002)64

HBsAg-, 

anti-HBc+, 

serum HBV-DNAlymphocyte HBV-DNA 1 20% Blanes et al. (2002)64
46

HBV Transmission from Lung Transplantation

Studies measured virus transmission in two different waysfor the transmission of HBV from lung 

transplantation (Table 17). Both rates were 0%. The reported resultsare shown graphically in the lower 

section of Figure 7 (above).

Table 17. LUNG Transplantation: Ranges of HBV Results

Donor was:

Recipient was tested 

for post-transplant 

positivity of:

# of 

Studies

Range of 

Results Studies

HBsAg-, anti-HBc+ HBsAg 1 0% Hartwig et al. (2005)65

HBsAg-, anti-HBc+ anti-HBc 1 0% Hartwig et al. (2005)65

HCV Transmission from Liver Transplantation

Studies measured virus transmission in three different waysfor the transmission of HCV from liver 

transplantation (Table 18). The reported resultsare shown graphically in Figure 8.

Table 18. LIVER Transplantation: Ranges of HCV Results

Donor was:

Recipient was tested

for post-transplant 

positivity of:

# of 

Studies

Range of 

Results Studies

anti-HCV+ anti-HCV 1 24% Shah et al. (1993)12,16

anti-HCV+, 

serum HCV-RNA+

anti-HCV 1 67% Everhart et al. (1999)66

anti-HCV+, 

serum HCV-RNA+

HCV-RNA 1 100% Everhart et al. (1999)66
47

Figure 8. LIVER transplantation: HCV Positivity in Recipients After the Use of

Organs Donors Positive for HCV

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Transmission rate

LIVER TRANSPLANT

anti-HCV+

anti-HCV+,

serum HCV+

anti-HCV

HCV-RNA

DONOR

was:

RECIPIENT was 

post-transplant

positive for:

anti-HCV

anti-HCV+,

serum HCV+

Note: This figure displays the reported rates of positivivity among pre-transplant negative recipients after receiving 

organs from positive donors. The title of the figure indicates the relevant pathogen(s) and organ(s). These data 

also appear in Table 26. The definitions of donor positivity appear on the left side of the figure, and the 

definitions of recipient post-transplant positivity appear on the right side of the figure. Prophylaxis was not 

generally applicable to the HCV studies, therefore all studies are represented by X’s.
48

HCV Transmission from Kidney Transplantation

Studies measured virus transmission in eight different ways for the transmission of HCV from kidney 

transplantation (Table 19). The reported resultsare shown graphically in Figure 9 below.

Table 19. KIDNEY Transplantation: Ranges of HCV Results

Donor was:

Recipient was tested 

for post-transplant 

positivity of:

# of 

Studies

Range of 

Results Studies

anti-HCV+ anti-HCV 8 6% to 91% Abbott et al. (2004)67,68, 

Rozental et al. (2002)69, 

Tokumoto et al. (1996)70, 

Tokumoto et al. (1996)70, 

Wreghitt et al. (1994)71, 

Mendez et al. (1993)72,73, 

Pereira et al. (1992)14,17-19, 

Roth et al. (1992)15,20

anti-HCV+ HCV-RNA 2 50% to 100% Tokumoto et al. (1996)70, 

Wreghitt et al. (1994)71

anti-HCV+, 

serum HCV-RNA+

anti-HCV 2 0% to 19% Tesi et al. (1994)74,75, 

Vincenti et al. (1993)13

anti-HCV+, 

serum HCV-RNA+

anti-HCV or 

indeterminate 

1 35% Tesi et al. (1994)74,75

anti-HCV+, 

serum HCV-RNA+

HCV-RNA 2 0% to 57% Tesi et al. (1994)74,75, 

Vincenti et al. (1993)13

anti-HCV+, 

serum HCV-RNA+

RIA 1 0% Vincenti et al. (1993)13

anti HCV+ and 

RIBA+

anti-HCV 1 62% Preiksaitis et al. (1997)76

anti HCV+ and 

RIBA+

HCV-RNA 1 67% Preiksaitis et al. (1997)76
49

Figure 9. KIDNEY Transplantation: HCV Positivity in Recipients After the Use of

Organs from Donors Positive For HCV

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Transmission rate

anti-HCV

HCV-RNA

Radio-immuno-assay

KIDNEY TRANSPLANT

anti-HCV+

anti-HCV+,

serum HCV+

anti-HCV

anti-HCV OR indeterminate

HCV-RNA

DONOR

was:

RECIPIENT was 

post-transplant

positive for:

anti-HCV+,

RIBA+

anti-HCV

HCV-RNA

Note: This figure displays the reported rates of positivivity among pre-transplant negative recipients after receiving 

organs from positive donors. The title of the figure indicates the relevant pathogen(s) and organ(s). These data 

also appear in Table 26. The definitions of donor positivity appear on the left side of the figure, and the 

definitions of recipient post-transplant positivity appear on the right side of the figure. Prophylaxis was not 

generally applicable to the HCV studies, therefore all studies are represented by X’s.
50

HCV Transmission from Heart Transplantation

Studies measured virus transmission in six different waysfor the transmission of HCV from heart 

transplantation (Table 20). The reported results are shown graphically in Figure 10.

Table 20. HEART Transplantation: Ranges of HCV Results

Donor was:

Recipient was tested 

for post-transplant 

positivity of:

# of 

Studies

Range of 

Results Studies

anti-HCV+ “detectable” anti-HCV 3 11% to 24% Haji et al. (2004)77-79, 

Gudmundsson et al. (2003)80, 

Marelli et al. (2002)81

anti-HCV+ HCV-RNA 3 12% to 75% Haji et al. (2004)77-79, 

Gudmundsson et al. (2003)80, 

Marelli et al. (2002)81

anti-HCV+ liver HCV 1 29% Gudmundsson et al. (2003)80

anti-HCV+ “Any HCV infection” 1 43% Gudmundsson et al. (2003)

80

anti-HCV+, 

serum HCV-RNA+

anti-HCV 1 44% File et al. (2003)34

anti-HCV+, 

serum HCV-RNA+

HCV-RNA 1 100% File et al. (2003)34
51

Figure 10. HEART Transplantation: HCV Positivity in Recipients After the Use of

Organs from Donors Positive for HCV

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Transmission rate

HEART TRANSPLANT

anti-HCV+

anti-HCV+,

serum HCV+

"detectable" anti-HCV

anti-HCV

HCV-RNA

liver HCV

"Any HCV infection"

anti-HCV

HCV-RNA

DONOR

was:

RECIPIENT was 

post-transplant

positive for:

Note: This figure displays the reported rates of positivivity among pre-transplant negative recipients after receiving 

organs from positive donors. The title of the figure indicates the relevant pathogen(s) and organ(s). These data 

also appear in Table 26. The definitions of donor positivity appear on the left side of the figure, and the 

definitions of recipient post-transplant positivity appear on the right side of the figure. Prophylaxis was not 

generally applicable to the HCV studies, therefore all studies are represented by X’s.
52

GRADE Assessment of Transmission 

The GRADE table for this question appears in Table 21; the seven categories of evidence were graded 

separately. There are numerous permutations of antigens/antibodies, and the committee decided that of 

these, the most critical HBV results were when the donor was positive for anti-HBc and may or may not 

have been HBsAg+ (e.g., studies where donor HBsAg status was not reported).The only exception to this 

was when the recipient was being tested for anti-HBs, which was not considered critical. For HCV, we 

considered it a critical result whenever the donor was positive for HCV RNA. To acknowledge these 

priorities, we shaded the rows summarizing and grading the corresponding evidence. The unshaded rows 

represent less critical results. For the seven categories of evidence, the primary reasons for the Low or 

Very Low grades involve study quality and consistency. Results were often widely different, even within 

the specific antigens and antibodies being tested.
53

Table 21. GRADE Table for Question 2 (Transmission)

Definitions 

of Donor 

Positivity

Recipient 

tested for:

Quantity 

and Type of 

Evidence

Range of 

Results

Starting Grade

Decrease GRADE Increase GRADE

GRADE 

of 

Evidence 

for 

Outcome

Overall 

GRADE 

of

Evidence 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Base

-response

Confounders would reduce the effect

HBV and Liver Transplantation

Anti-HBc+ HBsAg 5 OBS35-42 0% to 94% High -1 -1 0 0 0 0 0 0 Low

Low

Anti-HBc+ HBeAg 2 OBS38-42 40% to 94% High -2 -1 0 0 0 0 0 0 Very Low

Anti-HBc+ anti-HBc 2 OBS35,36 0% to 78% High -1 -1 0 0 0 0 0 0 Low

Anti-HBc+ serum HBVDNA

2 OBS38-42 40% to 94% High -1 -1 0 0 0 0 0 0 Low

Anti-HBc+ “Developed 

de novo 

infection”

1 OBS43 6% High -2 -1 0 0 0 0 0 0 Very Low

Anti-HBc+ anti-HBs 2 OBS35,36 0% to 44% High -1 -1 0 0 0 0 0 0 Low

Anti-HBc+ 

and HBsAgHBsAg 9 OBS

32,33,44-51

0% to 78% High -2 -1 0 0 0 0 0 0 Very Low

Anti-HBc+ 

and HBsAgHBeAg 2 OBS32,50 13% to 67% High -2 -1 0 0 0 0 0 0 Very Low

Anti-HBc+ 

and HBsAganti-HBs 2 OBS51,52 0% to 5% High -1 0 0 0 0 0 0 0 Moderate

Anti-HBc+ 

and HBsAganti-HBc 3 OBS46,47,52 0% to 37% High -1 -1 0 0 0 0 0 0 Low
54

Definitions 

of Donor 

Positivity

Recipient 

tested for:

Quantity 

and Type of 

Evidence

Range of 

Results

Starting Grade

Decrease GRADE Increase GRADE

GRADE 

of 

Evidence 

for 

Outcome

Overall 

GRADE 

of

Evidence 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Base

-response

Confounders would reduce the effect

Anti-HBc+ 

and HBsAgliver HBVDNA

2 OBS46,50 0% to 13% High -2 -1 0 0 0 0 0 0 Very Low

Anti-HBc+ 

and HBsAgserum HBVDNA

6 OBS

32,46,48-50,52,53

0% to 71% High -1 -1 0 0 0 0 0 0 Low

Anti-HBc+ 

and HBsAglymphocytes HBV-DNA

1 OBS49 0% High 0 -1 0 0 0 0 0 0 Moderate

HBV and Kidney Transplantation

anti-HBc+ HBsAg 1OBS42 0% High -2 0 0 0 0 0 0 0 Low

Low

anti-HBc+ HBeAg 1 OBS42 0% High -2 -1 0 0 0 0 0 0 Very Low

anti-HBc+ anti-HBc 1OBS42 0% High -2 0 0 0 0 0 0 0 Low

anti-HBc+ serum HBVDNA

1 OBS42 0% High -2 -1 0 0 0 0 0 0 Very Low

anti-HBc+ anti-HBs 1 OBS42 0% High -2 -1 0 0 0 0 0 0 Very Low

HBsAg-, 

anti-HBc+

HBsAg 6 OBS

44,45,51,54-57

0% High -1 0 0 0 0 0 0 0 Moderate

HBsAg-, 

anti-HBc+

anti-HBs 4 OBS51,56-58 0% to 11% High -1 0 0 0 0 0 0 0 Moderate

HBsAg-, 

anti-HBc+

anti-HBc 7 OBS

44,45,51,54-58

0% to 13% High -1 0 0 0 0 0 0 0 Moderate
55

Definitions 

of Donor 

Positivity

Recipient 

tested for:

Quantity 

and Type of 

Evidence

Range of 

Results

Starting Grade

Decrease GRADE Increase GRADE

GRADE 

of 

Evidence 

for 

Outcome

Overall 

GRADE 

of

Evidence 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Base

-response

Confounders would reduce the effect

HBsAg-, 

anti-HBc+

anti-HBs and 

anti-HBc

1 OBS57 0% High -1 -1 0 0 0 0 0 0 Low

HBsAg-, 

anti-HBc+

“HBV viremia” 1 OBS58 0% High -2 -1 0 0 0 0 0 0 Very Low

HBsAg-, 

anti-HBc+, 

serum HBVDNAHBsAg 1 OBS59 0% High -2 -1 0 0 0 0 0 0 Very Low

HBsAg-, 

anti-HBc+, 

serum HBVDNAanti-HBc 1 OBS59 0% High -2 -1 0 0 0 0 0 0 Very Low

HBsAg-, 

anti-HBc+, 

serum HBVDNAserum HBVDNA

1 OBS59 0% High -2 -1 0 0 0 0 0 0 Very Low

HBV and Heart Transplantation

anti-HBc+ HBsAg 2 OBS42,60 0% to 4% High -2 0 0 0 0 0 0 0 Low

Very Low

anti-HBc+ anti-HBc 2 OBS42,61 18% to 65% High -2 -1 0 0 0 0 0 0 Very Low

anti-HBc+ anti-HBs 3 OBS42,60,61 8% to 48% High -1 -1 0 0 0 0 0 0 Low

HBsAg-, 

anti-HBc+

HBsAg 1 OBS44,45 0% High -2 -1 0 0 0 0 0 0 Very Low
56

Definitions 

of Donor 

Positivity

Recipient 

tested for:

Quantity 

and Type of 

Evidence

Range of 

Results

Starting Grade

Decrease GRADE Increase GRADE

GRADE 

of 

Evidence 

for 

Outcome

Overall 

GRADE 

of

Evidence 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Base

-response

Confounders would reduce the effect

HBsAg-, 

anti-HBc+, 

anti-HBs+

HBsAg 1 OBS62,63 0% High -1 -1 0 0 0 0 0 0 Low

HBsAg-, 

anti-HBc+, 

serum HBVDNAHBsAg 1 OBS64 0% High -2 -1 0 0 0 0 0 0 Very Low

HBsAg-, 

anti-HBc+, 

serum HBVDNAanti-HBc 1 OBS64 0% High -2 -1 0 0 0 0 0 0 Very Low

HBsAg-, 

anti-HBc+, 

serum HBVDNAserum HBVDNA

1 OBS64 0% High -2 -1 0 0 0 0 0 0 Very Low

HBsAg-, 

anti-HBc+, 

serum HBVDNAlymphocyte 

HBV-DNA

1 OBS64 20% High -2 -1 0 0 0 0 0 0 Very Low

HBV and Lung Transplantation

HBsAg-, 

anti-HBc+

HBsAg 1 OBS65 0% High -1 -1 0 0 0 0 0 0 Low

Low

HBsAg-, 

anti-HBc+

anti-HBc 1 OBS65 0% High -1 -1 0 0 0 0 0 0 Low
57

Definitions 

of Donor 

Positivity

Recipient 

tested for:

Quantity 

and Type of 

Evidence

Range of 

Results

Starting Grade

Decrease GRADE Increase GRADE

GRADE 

of 

Evidence 

for 

Outcome

Overall 

GRADE 

of

Evidence 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Base

-response

Confounders would reduce the effect

HCV and Liver Transplantation

anti-HCV+ anti-HCV 1 OBS12,16 24% High -2 -1 0 0 0 0 0 0 Very Low

Low

anti-HCV+, 

serum HCVRNA+

anti-HCV 1 OBS66 67% High -1 -1 0 0 0 0 0 0 Low

anti-HCV+, 

serum HCVRNA+

HCV-RNA 1 OBS66 100% High -1 -1 0 0 0 0 0 0 Low

HCV and Kidney Transplantation

anti-HCV+ anti-HCV 8 OBS14,15,17-

20,67-70,70-73

6% to 91% High -2 -1 0 0 0 0 0 0 Very Low

Very Low

anti-HCV+ HCV-RNA 2 OBS70,71 50% to 100% High -1 -1 0 0 0 0 0 0 Low

anti-HCV+, 

serum HCVRNA+

anti-HCV 2 OBS13,75 0% to 19% High -2 -1 0 0 0 0 0 0 Very Low

anti-HCV+, 

serum HCVRNA+

anti-HCV or 

indeterminate 

1 OBS74,75 35% High -2 -1 0 0 0 0 0 0 Very Low

anti-HCV+, 

serum HCVRNA+

HCV-RNA 2 OBS13,74,75 0% to 57% High -2 -1 0 0 0 0 0 0 Very Low
58

Definitions 

of Donor 

Positivity

Recipient 

tested for:

Quantity 

and Type of 

Evidence

Range of 

Results

Starting Grade

Decrease GRADE Increase GRADE

GRADE 

of 

Evidence 

for 

Outcome

Overall 

GRADE 

of

Evidence 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Base

-response

Confounders would reduce the effect

anti-HCV+, 

serum HCVRNA+

RIA 1 OBS13 0% High -2 -1 0 0 0 0 0 0 Very Low

anti-HCV+

RIBA+

anti-HCV 1 OBS76 62% High -2 -1 0 0 0 0 0 0 Very Low

anti-HCV+

RIBA+

HCV-RNA 1 OBS76 67% High -2 -1 0 0 0 0 0 0 Very Low

HCV and Heart Transplantation

anti-HCV+ anti-HCV 3 OBS77-81 11% to 24% High -2 0 0 0 0 0 0 0 Low

Very Low

anti-HCV+ HCV-RNA 3 OBS77-81 12% to 75% High -2 -1 0 0 0 0 0 0 Very Low

anti-HCV+ liver HCV 1 OBS80 29% High -2 -1 0 0 0 0 0 0 Very Low

anti-HCV+ “Any HCV 

infection”

1 OBS80 43% High -2 -1 0 0 0 0 0 0 Very Low

anti-HCV+, 

serum HCVRNA+

anti-HCV 1 OBS34 44% High -2 -1 0 0 0 0 0 0 Very Low

anti-HCV+, 

serum HCVRNA+

HCV-RNA 1 OBS34 100% High -2 -1 0 0 0 0 0 0 Very Low

Note: The shaded rows denote evidence on rates where the donor was positive for anti-HBc but it was not reported whether the donor was positive for HBsAg; 

these were considered “critical” outcomes. The only expectation to this was when the recipient was being tested for anti-HBs, which was not considered 

critical. For HCV, we considered the result critical whenever the donor was positive for HCV RNA (thus the row was shaded).
59

Additional Evidence Tables for Question 2

Table 22. Question 2: General Information about Included Studies

Study Country

Center(s) or 

Program

KidneyLiverHeartLungCentersTransplantation dates

Funding

Studies of HBV Transmission

De Feo et al. (2005)44,45 Italy North Italy 

Transplant program

   39 Jan-97 to 

Dec-99

Supported in part by a grant 

from the Italian Institute of 

Health

Kadian et al. (1994)42 USA Mount Sinai Medical 

Center (NY)

   1 Sep-90 to 

Jun-92

Not reported (NR)

Akalin et al. (2005)58 USA Mt. Sinai School of 

Medicine, 

New York, NY

 1 NR NR

Veroux et al. (2005)54 Italy University Hospital of 

Catania

 1 Jan-01 to 

Jun-04

NR

Miedouge et al. (2003)59 France Toulouse University 

Hospital

 1 Jan-99 to 

Nov-01

NR

Fong et al. (2002)55 USA UNOS Scientific 

Renal Transplant 

Registry

 >1 1994 to 

1999

NR

Madayag et al. (1997)56 USA University of 

Maryland, 

Baltimore, MD

 1 Jan-92 to 

Jul-96

NR

Satterthwaite et al. (1997)57 USA St. Vincent Medical 

Center, 

Los Angeles, CA

 1 1990 to 

1995

NR
60

Study Country

Center(s) or 

Program

KidneyLiverHeartLungCentersTransplantation dates

Funding

Wachs et al. (1995)51 USA University of 

California 

(San Francisco, CA)

 1 Jun-85 to 

Dec-93

NR

Donataccio et al. (2006)47 Belgium Universite catholique 

de Louvain

 1 Feb-92 to 

Mar-04

One author was the 

recipient of a grant from 

Associzaone Italiana 

Trapiantati di Fegato 

(AITF), First Department of 

General Surgery, Verona 

University, Verona Italy

Suehiro et al. (2005)48 Japan Gunma University 

Hospital or 

Kyushu University 

Hospital

 2 Oct-96 to 

Mar-03

Supported in part by a 

Grant-in-Aid for Scientific 

Research and the 21st 

Century COE Program from 

the Ministry of Education, 

Culture, Sports Science and 

Technology, Japan

Montalti et al. (2004)43 Italy University of Bologna  1 Apr-86 to 

Jan-02

NR

Fabrega et al. (2003)49 Spain University Hospital 

Marques de 

Valdecilla

 1 Nov-99 to 

Mar-02

Fundacion Marques del 

Valdecilla

Loss et al. (2003)31,53 USA Ochsner Clinic 

Foundation, 

New Orleans, LA

 1 Jan-99 to 

Aug-01

NR
61

Study Country

Center(s) or 

Program

KidneyLiverHeartLungCentersTransplantation dates

Funding

Nery et al. (2003)50 USA Jackson Memorial 

Hospital Medical 

Center, 

Miami, FL

 1 Mar-96 to 

Mar-02

NR

Castells et al. (2002)52 Spain Hospital General Vall 

d’Hebron

 1 Jun-94 to 

Jun-00

NR

Holt et al. (2002)46 USA Loyola University 

Medical Center, 

Chicago, IL

 1 Feb-98 to 

Mar-01

NR

Roque-Afonso et al. (2002)36 France Hospital Paul 

Brousse

 1 Jan-97 to 

Sep-00

NR

Preito et al. (2001)32 Spain University Hospital la 

Fe

 1 Mar-95 to 

Dec-98

NR

Yu et al. (2001)35 USA Cedars-Sinai 

Medical Center, 

Los Angeles, CA

 1 Mar-96 to 

Mar-00

NR

Dodson et al. (1999)37 USA Thomas E. Starzl 

Transplantation 

Institute, 

Pittsburgh, PA

 1 Aug-96 to 

Jun-98

NR

Uemoto et al. (1998)38-41 Japan Kyoto University  1 Jun-90 to 

Jun-95

Scientific Research Fund of 

the Ministry of Education in 

Japan
62

Study Country

Center(s) or 

Program

KidneyLiverHeartLungCentersTransplantation dates

Funding

Dickson et al. (1997)33 USA University of Virginia 

Hospital 

(Charlottesville, VA), 

Mayo Clinic 

(Rochester, MN),

University of 

Nebraska 

(Omaha, NE), and 

University of 

California 

(San Francisco, CA)

 4 Aug-89 to 

Jun-94

NR

Pinney et al. (2005)60 USA Columbia 

Presbyterian Medical 

Center, New York, 

NY

 1 Jan-97 to 

Dec-02

NR

Tenderich et al. (2005)61 Germany Herz und 

Diabeteszentrum 

NRW

 1 Feb-99 to 

May-04

NR

Blanes et al. (2002)64 Spain University Hospital la 

Fe

 1 Jan-95 to 

Jun-99

NR

Ko et al. (2001)

62,63 Taiwan National Taiwan 

University Hospital

 1 Jan-92 to 

Aug-99

NR

Hartwig et al. (2005)65 USA Duke University 

Medical Center, 

Durham, NC

 1 Apr-01 to 

Aug-03

“The authors have no 

conflict of interest with 

regard to this work”
63

Study Country

Center(s) or 

Program

KidneyLiverHeartLungCentersTransplantation dates

Funding

Studies of HCV Transmission

Abbott et al. (2004)67,68 USA United States Renal 

Data System 

(USRDS)

 >1 Jan-96 to 

Jul-00

Supported in part by a grant 

NIDDK. One author had 

received an award from the 

American Kidney Fund.

Rozental et al. (2002)69 Latvia P. Stradin Clinical 

University Hospital

 1 1997 to 

Jul-01

NR

Preiksaitis et al. (1997)76 Canada University of Alberta 

Hospitals, Alberta

 1 1984 to 

Apr-92

NR

Tokumoto et al. (1996)70 Japan Nigata University  1 Nov-89 to 

Nov-92

NR

Tesi et al. (1994)74,75 USA Ohio State 

University, 

Columbus, OH

 1 Sep-90 to 

Jan-93a

NR

Wreghitt et al. (1994)71 UK Cambridge or 

Papworth

 2 1984 to 

1991

Bloomsbury and Islington 

Health Authority

Mendez et al. (1993)72,73 USA St. Vincent Medical 

Center, 

Los Angeles, CA

 1 Jul-90 to 

Jun-92

NR

Vincenti et al. (1993)13 USA University of 

California 

(San Francisco, CA)

 1 Jan-86 to 

Dec-88

NR
64

Study Country

Center(s) or 

Program

KidneyLiverHeartLungCentersTransplantation dates

Funding

Pereira et al. (1992)14,17-19 USA New England Organ 

Bank (MA)

 14 1986 to 

1990

International Society of 

Nephrology, New England 

Organ Bank, Nephrology 

Clinical Research 

Fellowship Training 

Program. One author was a 

stockholder in Ortho 

Diagnostic Systems, and 

three authors were 

stockholders in Chiron 

Corporation.

Roth et al. (1992)15,20 USA Jackson Memorial 

Hospital Medical 

Center, 

Miami, FL

 >1 Jan-79 to 

Feb-91

Miami Veterans Affairs 

Hospital Research Support

and NIH DK grant

Everhart et al. (1999)66 USA Mayo Clinic 

(Rochester, MN),

University of 

Nebraska 

(Omaha, NE), and 

University of 

California 

(San Francisco, CA)

 3 Apr-90 to 

Jun-94

Support from NIH NO1-DK 

grants

Shah et al. (1993)12,16 USA Presbyterian 

University Hospital, 

Pittsburgh, PA

 1 Mar-86 to 

Mar-90

Supported in part by grants 

from NIDDK

Haji et al. (2004)77-79 USA Cleveland Clinic, 

Cleveland, OH

 1 Jul-93 to 

Dec-98

NR
65

Study Country

Center(s) or 

Program

KidneyLiverHeartLungCentersTransplantation dates

Funding

File et al. (2003)34 USA Ochsner Clinic 

Foundation, 

New Orleans, LA

 1 1991 to 

1999

NR

Gudmundsson et al. (2003)80 USA Advanced Heart 

Failure/Heart 

Transplant Program, 

Maywood, IL

 1 Jan-95 to 

Jul-97

Robert D. Van Kampen 

Research Fund

Marelli et al. (2002)81 USA University of 

California 

(Los Angeles, CA)

 1 Jul-94 to 

Dec-99

NR

a

January 1993 is an approximate estimate of the latest transplant date (based on the publication date of the primary publication of March 1994), so that the study 

could be included in the plot of transplant dates.

NR – Not reported.
66

Table 23. Question 2: Details of Study Methods

Study

ProspectiveConsecutive

Prophylaxis

Frequency of 

Posttransplant 

Serological 

Testing

Duration of 

Posttransplant 

Follow-up

If any de novo

infections 

occurred, 

how long 

after surgery 

did they 

occur? Diagnostic Tests

Studies of HBV Transmission

De Feo et al. (2005)44,45 No No NR NR NR NR Microparticle Enzyme 

Immunoassay for HBV, and 

ImxCORE and ImxAVSAB

Kadian et al. (1994)42 No No NR NR Range:

12-33 months

Liver: 

Range:

8-16 months;

Kidney: 

no positives 

after transplant;

Heart: NR

NR

Akalin et al. (2005)58 NR NR Lamivudine NR Median: 

36 months

(Range: 6-60)

NA Tests NR; PCR for 

HBV-DNA

Veroux et al. (2005)54 No Yes HBIg NR Mean: 

17 months

(Range: 6-48)

NR NR

Miedouge et al. (2003)59 No Yes NR NR Mean: 

11 months

(Range: 6-29)

NA Abbott Diagnostics and 

AxSYM for HBV, and 

Amplicor for HBV-DNA
67

Study

ProspectiveConsecutive

Prophylaxis

Frequency of 

Posttransplant 

Serological 

Testing

Duration of 

Posttransplant 

Follow-up

If any de novo

infections 

occurred, 

how long 

after surgery 

did they 

occur? Diagnostic Tests

Fong et al. (2002)55 No Yes NR “The majority 

of centers 

do not perform 

routine HBsAg 

or anti-HBc 

testing”

NR NR NR

Madayag et al. (1997)56 No Yes NR Performed 

“regularly” after 

transplant; 

no frequency 

reported

Range:

6-36 months

Range:

3-12 months

Abbott Diagnostics for HBV 

Satterthwaite et al. (1997)57 No Yes No HBIg, NR 

others

NR NR NR NR

Wachs et al. (1995)51 No No NR NR NR NR NR

Donataccio et al. (2006)47 No Yes Of 11 patients, 

4 had none, 

6 had HBIg, and 

one had both 

HBIg and 

lamivudine

At weeks 1, 2, 

3, 4, then at 

months 2, 3, 6 

and 12, and 

then yearly. 

Liver biopsy 

at days 0, 7, 

and also 6 mo. 

And 12 mo.

Infections 

occurred at a 

median of 

27 months 

(Range: 12-60) 

after transplant

NR AxSYM or Abbott 

Diagnostics for HBV 
68

Study

ProspectiveConsecutive

Prophylaxis

Frequency of 

Posttransplant 

Serological 

Testing

Duration of 

Posttransplant 

Follow-up

If any de novo

infections 

occurred, 

how long 

after surgery 

did they 

occur? Diagnostic Tests

Suehiro et al. (2005)48 NR No HBIg and 

lamivudine

At weeks 1, 2, 

3, 4, then 

monthly for 

one year, 

then every 

three months.

Mean: 

38.5 months

(Range: 25-86)

NA Abbott Diagnostics for 

HBV, and Amplicor PCR for 

HBV-DNA

Montalti et al. (2004)43 No Yes NR for the 

18 negative 

recipients; of 44 

total recipients, 

11 received no 

prophylaxis, 

13 received 

HbIg, 

19 received 

both HbiG and 

lamivudine, and 

1 received 

lamivudine only

NR NR NR NR

Fabrega et al. (2003)49 Yes Yes HBIg At weeks 1, 2, 

4, and 13; 

every 

13 weeks 

thereafter

23 months

(Range: 9-36)

NA EIA or Sorin Miomedical for 

HBV
69

Study

ProspectiveConsecutive

Prophylaxis

Frequency of 

Posttransplant 

Serological 

Testing

Duration of 

Posttransplant 

Follow-up

If any de novo

infections 

occurred, 

how long 

after surgery 

did they 

occur? Diagnostic Tests

Loss et al. (2003)31,53 Yes Yes Recombivax HB, 

HBIg, and 

lamivudine

At weeks 1, 2, 

3, 4, then 

monthly for 

one year, 

then every 

three months.

5 months

(Range: 1-12)

NA Qiagen for HBV, 

PCR for HBsAg

Nery et al. (2003)50 No No Of 8 patients, 

1 had none, 6 

had lamivudine 

only, and 1 had 

both HBIg and 

lamivudine

Every 

1-6 months or 

at discretion of 

physician

minimum 

4 months

NR Abbott Diagnostics for 

HBV, and Qiagen for 

HBV-DNA, also in-house 

PCR

Castells et al. (2002)52 Yes No Engerix HB, and

lamivudine 

after transplant 

if infection 

detected

At months 1, 

3, and 6, 

then yearly

At least 

6 months

Median: 

24 months 

(Range: 6-48)

HBV using Abbott AxSYM; 

HBeAg and anti-Hbe using 

Diasorin; HBV-DNA using 

PCR

Holt et al. (2002)46 No Yes “Vaccination”, 

HBIg and 

lamivudine

“All patients 

have been 

followed 

closely in the 

follow-up 

period”. 

Liver biopsies 

at 6 mo., 

1 year, and 

2 years.

29 months

(Range: 6-29)

NA PCR on liver biopsy for 

HBV
70

Study

ProspectiveConsecutive

Prophylaxis

Frequency of 

Posttransplant 

Serological 

Testing

Duration of 

Posttransplant 

Follow-up

If any de novo

infections 

occurred, 

how long 

after surgery 

did they 

occur? Diagnostic Tests

Roque-Afonso et al. 

(2002)36

No Yes Of 9 patients, 

4 had none, and 

5 had HBIg

At least once 

every four 

months 

sometimes 

more often

Median: 24 

(Range: 6-45)

At months 8, 9, 

11, 15, and 17

anti-HBs using Dade 

Behring; anti-HBc using 

Merux Biotech; HBeAg 

using BioMerieux; 

HBV-DNA using Quantiplex

Preito et al. (2001)32 No No Some had 

lamivudine, but 

did not report

how many

At months 1, 3, 

and 6, then 

yearly or 

when clinically 

indicated

Mean: 24, 

SD: 14

Median time: 

12 months 

(Range: 3-24)

HBsAg using Abbott 

product; antiHBs and 

anti-HBc and anti-Hbe 

using Diasiron; HBV-DNA 

using PCR via Diogene

Yu et al. (2001)35 No Yes Lamivudine Did not report 

frequency of 

serological test 

monitoring; 

only analyzed 

the most 

recent 

serological test 

result; liver 

biopsy only 

when clinically 

indicated

Mean: 

17 months 

(Range: 2-40)

NA HBV-DNA with Qiogen and 

nested PCR

Dodson et al. (1999)37 Yes Yes Of 8 patients, 

1 had HBIg only, 

and the other 7 

had both HBIg 

and lamivudine

Daily for 7 

days, then 

monthly for 

6 months, 

then every 

six months

Median: 

15 months 

(Range: 7-20)

At 6 months NR
71

Study

ProspectiveConsecutive

Prophylaxis

Frequency of 

Posttransplant 

Serological 

Testing

Duration of 

Posttransplant 

Follow-up

If any de novo

infections 

occurred, 

how long 

after surgery 

did they 

occur? Diagnostic Tests

Uemoto et al. (1998)38-41 No Yes None NR NR The 15 new 

infections were 

found at a 

mean of 

one year 

(Range:

5-26 months)

Dinabot for HBV, and 

nested PCR for HBV-DNA

Dickson et al. (1997)33 No No NR When 

possible, 

samples were 

obtained at 

4 months, 

one year, and 

two years 

after transplant

Mean: 

19 months 

(Range: 4-60)

Median: 

12 months 

(Range: 2-37)

HBV using Abbott product; 

HBV-DAN by PCR via 

National Genetics Institute

Pinney et al. (2005)60 No Yes Some had 

lamivudine, but 

did not report

how many

Every year 

after transplant

NR The one 

infection 

occurred at 

10 months 

after transplant

NR
72

Study

ProspectiveConsecutive

Prophylaxis

Frequency of 

Posttransplant 

Serological 

Testing

Duration of 

Posttransplant 

Follow-up

If any de novo

infections 

occurred, 

how long 

after surgery 

did they 

occur? Diagnostic Tests

Tenderich et al. (2005)61 No Yes NR Within 

four months 

before 

transplant, and 

between 

six hours and

one year after 

transplant; 

did not report a 

standard 

monitoring 

frequency

NR HBV was 

“already 

detectable in 

several blood 

samples within 

6-10 hours 

after heart 

transplant”; 

others detected 

at 5 weeks and 

4 months 

after transplant

HBV using Abbott AxSYM; 

also analyzed two samples 

of Flebogamma

Blanes et al. (2002)64 No No NR NR Mean: 37.7 NR HBcAg using AxSYM; 

anti-HBc and anti-HBs 

using Diasorin; HBV-DNA 

by nested PCR

Ko et al. (2001)62,63 No No HBIg At least once 

every 

four weeks, 

sometimes 

more often

32 months

(Range: 6-98)

NA Well-cozyme or Chatillon 

for HBV, and Qiagen for 

HBV-DNA

Hartwig et al. (2005)65 No Yes Recombivax HB NR Median: 

21.5 months

NA NR
73

Study

ProspectiveConsecutive

Prophylaxis

Frequency of 

Posttransplant 

Serological 

Testing

Duration of 

Posttransplant 

Follow-up

If any de novo

infections 

occurred, 

how long 

after surgery 

did they 

occur? Diagnostic Tests

Studies of HCV Transmission

Abbott et al. (2004)67,68 No Yes NR NR Range:

6-36 months

NR ELISA2 or ELISA3

Rozental et al. (2002)69 No Yes NR NR 18 months 

(did not report 

whether this 

was a mean or 

median)

NR HCV using MEIA
74

Study

ProspectiveConsecutive

Prophylaxis

Frequency of 

Posttransplant 

Serological 

Testing

Duration of 

Posttransplant 

Follow-up

If any de novo

infections 

occurred, 

how long 

after surgery 

did they 

occur? Diagnostic Tests

Preiksaitis et al. (1997)76 No Yes NR One year after 

transplant, 

and/or the time 

of latest 

followup

Overall median 

followup of 

kidney 

recipients was 

54 months 

(range 9-154).

Positive antiHCV tests 

occurred in 8 

kidney 

recipients at an 

average of 22 

months after 

transplant 

(median 6.5 

months, range 

2 to 60.5). 

Positive HCV 

RNA tests 

occurred in 7

kidney 

recipients at an 

average of 5.9 

years after 

transplant 

(median 5.3 

years, range 2 

to 60.5).

Anti-HCV using Ortho HCV 

3.0 ELISA, RIBA using 

Chiron RIBA HCV 3.0 strip 

immunoblot assay, and 

HCV RNA by PCR using 

the Amplicor HCV virus 

test.

Tokumoto et al. (1996)70 Yes Yes Interferon Weeks 2, 4, 6, 

8, 10, 12, 16, 

20, and 24

Mean: 

40 months 

(Range: 30-65)

NR RIBA1; HCV-RNA using 

PCR

Tesi et al. (1994)74,75 Yes No NR NR Mean: 

20 months 

(Range: 2-38)

NR ELISA1, ELISA 2, 

Matrix (Abbott) and PCR
75

Study

ProspectiveConsecutive

Prophylaxis

Frequency of 

Posttransplant 

Serological 

Testing

Duration of 

Posttransplant 

Follow-up

If any de novo

infections 

occurred, 

how long 

after surgery 

did they 

occur? Diagnostic Tests

Wreghitt et al. (1994)71 No No NR Only the latest 

serological test 

results were 

analyzed

Mean: 41 

(Range: 12-72)

Two at 

7 months and 

9 months after 

transplantation; 

timing of other 

de novo 

infections were 

not reported

NR

Mendez et al. (1993)72,73 No Yes NR NR Range:

12-23 months

At 4 and 

11 months 

after transplant

ELISA2

Vincenti et al. (1993)13 No Yes NR NR Range:

36-40 months

NA HCV using Chiron-Orth; 

if reactive, then tested for 

HCV-RNA

Pereira et al. (1992)14,17-19 No No NR Only the most 

recent 

serological test 

was analyzed

Median: 

29 months 

(Range: 12-39)

NR ELISA2 and RIBA2; 

HCV-RNA using PCR

Roth et al. (1992)15,20 No No NR NR Median: 

55 months 

(Range: 3-73)

At 10 weeks 

after transplant

ELISA1, and if reactive, 

RIBA2

Everhart et al. (1999)66 Yes No NR At 4 months, 

one year,

two years and 

at study end 

(which was 

2-5 years after 

transplant)

NR NR ELISA2, and if that was 

reactive, then RIBA2; 

HCV-RNA using Amplicor
76

Study

ProspectiveConsecutive

Prophylaxis

Frequency of 

Posttransplant 

Serological 

Testing

Duration of 

Posttransplant 

Follow-up

If any de novo

infections 

occurred, 

how long 

after surgery 

did they 

occur? Diagnostic Tests

Shah et al. (1993)12,16 No No NR At six months, 

one year, and 

two years

NR Mean: 

21 months 

(plus or minus 

16; did not 

report whether 

the plus or 

minus meant 

SD, or SE, or 

CI, or IQR, or 

SIQR, or range)

ELISA2

Haji et al. (2004)77-79 No No NR NR Mean: 

50 months

(SD: 23)

NR ELISA2; HCV-RNA using 

PCR

File et al. (2003)34 No Yes NR Each patient 

was “tested on 

one or more 

occasions 

during routine 

clinical visits”; 

nothing else 

reported about 

monitoring 

frequency

NR NR ELISA2; HCV-RNA using 

PCR (Amplicor)

Gudmundsson et al. 

(2003)80

No Yes NR NR Mean: 

63 months 

(Range: 28-86)

At 19, 39, and 

55 months 

after transplant

ELISA2; HCV-RNA using 

PCR (Roche)
77

Study

ProspectiveConsecutive

Prophylaxis

Frequency of 

Posttransplant 

Serological 

Testing

Duration of 

Posttransplant 

Follow-up

If any de novo

infections 

occurred, 

how long 

after surgery 

did they 

occur? Diagnostic Tests

Marelli et al. (2002)81 No Yes NR NR Median: 

22 months 

(Range: 7-112)

NR ELISA2; HCV-RNA using 

PCR (Amplicor)

NA – Not applicable

NR – Not reported
78

Table 24. Question 2: Pre-transplant Patient Characteristics

Study Patient Characteristics Pre-transplant Mean (SD) or % (N/N) Comments

Studies of HBV Transmission

De Feo et al. (2005)44,45, 

Kadian et al. (1994)42, 

Akalin et al. (2005)58, 

Veroux et al. (2005)54, 

Miedouge et al. (2003)59, 

Madayag et al. (1997)56, 

Wachs et al. (1995)51, 

Donataccio et al. (2006)47, 

Montalti et al. (2004)43, 

Fabrega et al. (2003)49, 

Loss et al. (2003)31,53, 

Nery et al. (2003)50, 

Castells et al. (2002)52, 

Preito et al. (2001)32, 

Dodson et al. (1999)37, 

Uemoto et al. (1998)38-41, 

Dickson et al. (1997)33, 

Pinney et al. (2005)60, 

Blanes et al. (2002)64, 

Ko et al. (2001)62,63, 

Hartwig et al. (2005)65

These studies did not report pre-transplant characteristics for pre-transplant negative patients who received 

organs from positive patients

Fong et al. (2002)55 Cold ischemia time (hours) 22.1 (SD: 8.5)

Donor % African-American 17% (130/763)

Donor % death due to stroke 51% (389/763)

Donor % HCV+ 11% (84/763)

Donor % male 42% (320/763)

Donor mean age 40.5 (SD: 16)

Num. of HLA mismatches 3.7 (SD: 1.6)
79

Study Patient Characteristics Pre-transplant Mean (SD) or % (N/N) Comments

Recipient % African-American 34% (259/763)

Recipient % Asian-American 5% (38/763)

Recipient % being retransplanted 12% (92/763)

Recipient % HCV+ 11% (84/763)

Recipient % male 63% (481/763)

Recipient mean age 47.8 (SD: 13.1)

Recipient duration of dialysis (months) 38.1 (SD: 34.6)

Recipient Peak Panel Reactive Antibody 13.2 (SD: 24.3)

Satterthwaite et al. (1997)57 “Avermean age match” (not defined) 1.6 (SD: NR)

% with Cold ischemia time >36 hours 41% (11/27)

Recipient % age <12 7% (2/27)

Recipient % being retransplanted 11% (3/27)

Recipient % African-American 15% (4/27)

Recipient % Caucasian-American 44% (12/27)

Recipient % Hispanic-American 30% (8/27)

Recipient % Other race 4% (1/27)

Recipient % male 63% (17/27)

Recipient % with diabetes 15% (4/27)

Recipient panel reactive antibody <40 0% (0/27)

Suehiro et al. (2005)48 Donor % male 53% (8/15)

Donor mean age 43.3 (SD: 10.2)

Recipient % male 33% (5/15)

Recipient mean age 35.3 (SD: 14.4)
80

Study Patient Characteristics Pre-transplant Mean (SD) or % (N/N) Comments

Holt et al. (2002)46 Recipient % indication for transplant was 

active hepatitis, IgA deficiency

13% (1/8)

Recipient % indication for transplant was 

acute Budd-Chiari syndrome

13% (1/8)

Recipient % indication for transplant was 

alcoholic cirrhosis

13% (1/8)

Recipient % indication for transplant was 

chronic active HCV

13% (1/8)

Recipient % indication for transplant was 

fulminant liver failure

13% (1/8)

Recipient % indication for transplant was 

liver failure secondary to amyloidosis

13% (1/8)

Recipient % indication for transplant was 

primary biliary cirrhosis

13% (1/8)

Recipient % indication for transplant was 

primary biliary cirrhosis and scleroderma

13% (1/8)

Recipient % male 50% (4/8)

Recipient mean age 48.9 (SD: 13.5)

Roque-Afonso et al. (2002)36 Recipient % blood type A+ 56% (5/9)

Recipient % blood type B+ 11% (1/9)

Recipient % blood type O+ 33% (3/9)

Recipient % indication for transplant was 

alcoholic cirrhosis

44% (4/9)

Recipient % indication for transplant was 

Budd-Chiari syndrome

11% (1/9)

Recipient % indication for transplant was 

HCV+ alcoholic cirrhosis

11% (1/9)
81

Study Patient Characteristics Pre-transplant Mean (SD) or % (N/N) Comments

Recipient % indication for transplant was 

primary biliary cirrhosis

11% (1/9)

Recipient % indication for transplant was 

symptomatic amyloidosis

22% (2/9)

Yu et al. (2001)35 Recipient % indication for transplant was 

HCC (NR what this meant)

60% (3/5)

Recipient % indication for transplant was 

HCV cirrhosis

100% (5/5)

Tenderich et al. (2005)61 Recipient % indication for transplant was 

coronary heart disease

43% (10/23)

Recipient % indication for transplant was 

dilated cardiomyopathy

48% (11/23)

Recipient % male 83% (19/23)

Recipient % other indication for transplant 9% (2/23)

Recipient mean age 53.5 (“+/- 5.4”; NR 

what this meant)

Serum creatinine 1.25 (“+/- 0.49”; NR 

what this meant)

Recipient height (cm) 171 (“+/- 21”; NR what 

this meant)

Recipient left ventricular ejection fraction 

(%)

29.6 (“+/- 12.9”; NR 

what this meant)

Recipient serum creatinine 72.4 (“+/- 20.6”; NR 

what this meant)
82

Study Patient Characteristics Pre-transplant Mean (SD) or % (N/N) Comments

Studies of HCV transmission

Abbott et al. (2004)67,68, 

Rozental et al. (2002)69, 

Preiksaitis et al. (1997)76, 

Tesi et al. (1994)74,75, 

Wreghitt et al. (1994)71, 

Vincenti et al. (1993)13, 

Pereira et al. (1992)14,17-19, 

Everhart et al. (1999)66, 

Shah et al. (1993)12,16

These studies did not report pre-transplant characteristics for pre-transplant negative patients who received 

organs from positive patients

Tokumoto et al. (1996)70 Recipient HLA AB mismatch 1.3 (SD: 0.8)

Recipient HLA DR mismatch 0.7 (SD: 0.8)

Recipient % male 50% (3/6)

Recipient % received organs from 

deceased donors

50% (3/6)

Recipient mean age 36.7 (SD: 13.3)

Mendez et al. (1993)72,73 Donor % CMV+ 85% (28/33)

Recipient % CMV+ 76% (25/33)

Recipient % etiology diabetes 27% (9/33)

Recipient % etiology hypertension 18% (6/33)

Recipient % male 45% (15/33)

Recipient mean age 33 (SD: 11)

Recipient pre-transplant dialysis tie 

(months)

25 (SD: 6)

Recipient prior number of blood 

transfusions

9 (SD: 4)
83

Study Patient Characteristics Pre-transplant Mean (SD) or % (N/N) Comments

Roth et al. (1992)15,20 Donor % chronic active hepatitis 45% (5/11) 3 of the 14 donors’ pre-transplant 

CMV status was not reported

Donor % chronic persistent hepatitis 9% (1/11) 3 of the 14 donors’ pre-transplant 

CMV status was not reported

Donor % CMV+ 50% (7/14)

Donor % normal liver histology 45% (5/11) 3 of the 14 donors’ pre-transplant 

CMV status was not reported

Recipient % CMV+ 69% (9/13) 1 of the 14 recipients’ pre-transplant 

CMV status was not reported

Haji et al. (2004)77-79 % “Cause” was dilated cardiomyopathy 32% (11/34)

% “Cause” was ischemic cardiomyopathy 62% (21/34)

% “Cause” was something else 5% (2/34)

Donor % male 74% (25/34)

Donor mean age 39 (SD: 9)

Recipient % male 76% (26/34)

Recipient mean age 57 (SD: 10)

Recipient mean age biopsy score 1.31 (SD: 0.65)

Recipient episodes of acute rejection 

before this transplant

1.7 (SD: 1.5)

File et al. (2003)34 Recipient % history of alcohol abuse 10% (1/10)

Recipient % ischemic cardiomyopathy 100% (10/10)

Recipient % male 90% (9/10)

Recipient % UNOS status I 100% (10/10)

Recipient mean age 52 (SD: 7.1) SD calculated by ECRI Institute 

based on Table 1 of the article
84

Study Patient Characteristics Pre-transplant Mean (SD) or % (N/N) Comments

Gudmundsson et al. (2003)80 Recipient % anti-HBs+ 13% (1/8)

Recipient % indication for transplant was 

idiopathic dilation

25% (2/8)

Recipient % indication for transplant was 

ischemia

50% (4/8)

Recipient % indication for transplant was 

restrictive cardiomyopathy

13% (1/8)

Recipient % indication for transplant was 

valvular

13% (1/8)

Recipient % male 88% (7/8)

Recipient % UNOS status I 88% (7/8)

Recipient % with HCV+ serology 0% (0/8)

Recipient % with other positive HBV 

serology

0% (0/8)

Recipient mean age 55 (SD: NR)

Marelli et al. (2002)81 Recipient % UNOS status 1 56% (10/18)

SD – Standard deviation
85

Table 25. Question 2: Quality Assessment

Study 2a 2b 2c 2d

Studies of HBV Transmission

De Feo et al. (2005)44,45

Kadian et al. (1994)42

Akalin et al. (2005)58 

Veroux et al. (2005)54  

Miedouge et al. (2003)59 

Fong et al. (2002)55 

Madayag et al. (1997)56  

Satterthwaite et al. (1997)57  

Wachs et al. (1995)51

Donataccio et al. (2006)47  

Suehiro et al. (2005)48  

Montalti et al. (2004)43 

Fabrega et al. (2003)49    

Loss et al. (2003)31,53    

Nery et al. (2003)50 

Castells et al. (2002)52   

Holt et al. (2002)46   

Roque-Afonso et al. (2002)36  

Preito et al. (2001)32 

Yu et al. (2001)35  

Dodson et al. (1999)37    

Uemoto et al. (1998)38-41  

Dickson et al. (1997)33 

Pinney et al. (2005)60  

Tenderich et al. (2005)61  

Blanes et al. (2002)64

Ko et al. (2001)62,63  

Hartwig et al. (2005)65  
86

Study 2a 2b 2c 2d

Studies of HCV Transmission

Abbott et al. (2004)67,68 

Rozental et al. (2002)69 

Preiksaitis et al. (1997)76 

Tokumoto et al. (1996)70    

Tesi et al. (1994)74,75 

Wreghitt et al. (1994)71

Mendez et al. (1993)72,73 

Vincenti et al. (1993)13 

Pereira et al. (1992)14,17-19

Roth et al. (1992)15,20

Everhart et al. (1999)66  

Shah et al. (1993)12,16 

Haji et al. (2004)77-79

File et al. (2003)34 

Gudmundsson et al. (2003)80 

Marelli et al. (2002)81 

A checkmark () means that the study met the quality criterion for this Question; the lack of a checkmark means that 

the study either did not meet the criterion, or it was unclear whether the study met the criterion. The criteria specific to 

this Question were: 

2a. Was the study planned prospectively (i.e., before any data were collected)?

2b. Were all consecutive patients enrolled (or a random sample of eligible patients)?

2c. Were laboratory tests performed on recipients regularly in order to monitor antigens/antibodies? (Greater 

frequency means greater accuracy at estimating the rate.) 

2d. Did all patients receive the same prophylaxis strategy (or none received any prophylaxis)? (A mix of 

prophylaxis strategies means a less interpretable rate.)
87

Table 26. Question 2: Data Table of Results

Study

Specific Test 

Results in these 

Donors

The rate applies to 

recipient positivity 

for what specific 

antigen/antibody?

Percentage of recipients 

who tested positive

(95% CI) ¶

(Number of Recipients 

Positive Post-transplant/ 

Number of Recipients 

Negative Pre-transplant)

HBV Transmission from LIVER Transplantation

Roque-Afonso et al. (2002)36 anti-HBc+ HBsAg 56%

(95% CI: 27% to 81%)

(5/9)

Yu et al. (2001)35 anti-HBc+ HBsAg 0%

(95% CI: 0% to 43%)

(0/5)

Dodson et al. (1999)37 anti-HBc+ HBsAg 13%

(95% CI: 2% to 47%)

(1/8)

Uemoto et al. (1998)38-41 anti-HBc+ HBsAg 94%

(95% CI: 72% to 99%)

(15/16)

Kadian et al. (1994)42 anti-HBc+ HBsAg 40%

(95% CI: 17% to 69%)

(4/10)

Uemoto et al. (1998)38-41 anti-HBc+ HBeAg 94%

(95% CI: 72% to 99%)

(15/16)

Kadian et al. (1994)42 anti-HBc+ HBeAg 40%

(95% CI: 17% to 69%)

(4/10)

Roque-Afonso et al. (2002)36 anti-HBc+ anti-HBs 44%

(95% CI: 19% to 73%)

(4/9)

Yu et al. (2001)35 anti-HBc+ anti-HBs 0%

(95% CI: 0% to 43%)

(0/5)

Roque-Afonso et al. (2002)36 anti-HBc+ anti-HBc 78%

(95% CI: 45% to 94%)

(7/9)

Yu et al. (2001)35 anti-HBc+ anti-HBc 0%

(95% CI: 0% to 43%)

(0/5)

Uemoto et al. (1998)38-41 anti-HBc+ serum HBV-DNA 94%

(95% CI: 72% to 99%)

(15/16)
88

Study

Specific Test 

Results in these 

Donors

The rate applies to 

recipient positivity 

for what specific 

antigen/antibody?

Percentage of recipients 

who tested positive

(95% CI) ¶

(Number of Recipients 

Positive Post-transplant/ 

Number of Recipients 

Negative Pre-transplant)

Kadian et al. (1994)42 anti-HBc+ serum HBV-DNA 40%

(95% CI: 17% to 69%)

(4/10)

Montalti (2004)43 anti-HBc+ “Developed de novo 

infection”

6%

(95% CI: 1% to 26%)

(1/18)

De Feo et al. (2005)44,45 HBsAg-, 

anti-HBc+

HBsAg 43%

(95% CI: 21% to 67%)

(6/14)

Holt et al. (2002)46 HBsAg-, 

anti-HBc+

HBsAg 0%

(95% CI: 0% to 32%)

(0/8)

Donataccio et al. (2006)47 HBsAg-, 

anti-HBc+

HBsAg 64%

(95% CI: 35% to 85%)

(7/11)

Suehiro et al. (2005)48 HBsAg-, 

anti-HBc+

HBsAg 0%

(95% CI: 0% to 20%)

(0/15)

Fabrega et al. (2003)49 HBsAg-, 

anti-HBc+

HBsAg 0%

(95% CI: 0% to 39%)

(0/6)

Nery et al. (2003)50 HBsAg-, 

anti-HBc+

HBsAg 13%

(95% CI: 2% to 47%)

(1/8)

Preito et al. (2001)32 HBsAg-, 

anti-HBc+

HBsAg 71%

(95% CI: 50% to 86%)

(15/21)

Dickson et al. (1997)33 HBsAg-, 

anti-HBc+

HBsAg 78%

(95% CI: 58% to 90%)

(18/23)

Wachs et al. (1995)51 HBsAg-, 

anti-HBc IgM+

HBsAg 60%

(95% CI: 23% to 88%)

(3/5)

Nery et al. (2003)50 HBsAg-, 

anti-HBc+

HBeAg 13%

(95% CI: 2% to 47%)

(1/8)

Preito et al. (2001)32 HBsAg-, 

anti-HBc+

HBeAg 67%

(95% CI: 45% to 83%)

(14/21)
89

Study

Specific Test 

Results in these 

Donors

The rate applies to 

recipient positivity 

for what specific 

antigen/antibody?

Percentage of recipients 

who tested positive

(95% CI) ¶

(Number of Recipients 

Positive Post-transplant/ 

Number of Recipients 

Negative Pre-transplant)

Castells et al. (2002)52 HBsAg-, 

anti-HBc+

anti-HBs 5%

(95% CI: 1% to 25%)

(1/19)

Wachs et al. (1995)51 HBsAg-, 

anti-HBc IgM+

anti-HBs 0%

(95% CI: 0% to 43%)

(0/5)

Holt et al. (2002)46 HBsAg-, 

anti-HBc+

anti-HBc 0%

(95% CI: 0% to 32%)

(0/8)

Donataccio et al. (2006)47 HBsAg-, 

anti-HBc IgM+

anti-HBc 20%

(95% CI: 4% to 62%)

(1/5)

Castells et al. (2002)52 HBsAg-, 

anti-HBc+

anti-HBc 37%

(95% CI: 19% to 59%)

(7/19)

Holt et al. (2002)46 HBsAg-, 

anti-HBc+

liver HBV-DNA 0%

(95% CI: 0% to 32%)

(0/8)

Nery et al. (2003)50 HBsAg-, 

anti-HBc+

liver HBV-DNA 13%

(95% CI: 2% to 47%)

(1/8)

Holt et al. (2002)46 HBsAg-, 

anti-HBc+

serum HBV-DNA 0%

(95% CI: 0% to 32%)

(0/8)

Suehiro et al. (2005)48 HBsAg-, 

anti-HBc+

serum HBV-DNA 0%

(95% CI: 0% to 20%)

(0/15)

Fabrega et al. (2003)49 HBsAg-, 

anti-HBc+

serum HBV-DNA 0%

(95% CI: 0% to 39%)

(0/6)

Loss et al. (2003)31,53 HBsAg-, 

anti-HBc+

serum HBV-DNA 0%

(95% CI: 0% to 43%)

(0/5)

Nery et al. (2003)50 HBsAg-, 

anti-HBc+

serum HBV-DNA 13%

(95% CI: 2% to 47%)

(1/8)

Castells et al. (2002)52 HBsAg-, 

anti-HBc+

serum HBV-DNA 0%

(95% CI: 0% to 17%)

(0/19)
90

Study

Specific Test 

Results in these 

Donors

The rate applies to 

recipient positivity 

for what specific 

antigen/antibody?

Percentage of recipients 

who tested positive

(95% CI) ¶

(Number of Recipients 

Positive Post-transplant/ 

Number of Recipients 

Negative Pre-transplant)

Preito et al. (2001)32 HBsAg-, 

anti-HBc+

serum HBV-DNA 71%

(95% CI: 50% to 86%)

(15/21)

Fabrega et al. (2003)49 HBsAg-, 

anti-HBc+

lymphocytes HBVDNA0%

(95% CI: 0% to 39%)

(0/6)

HBV Transmission from KIDNEY Transplantation

Kadian et al. (1994)42 anti-HBc+ HBsAg 0%

(95% CI: 0% to 22%)

(0/14)

Kadian et al. (1994)42 anti-HBc+ HBeAg 0%

(95% CI: 0% to 22%)

(0/14)

Kadian et al. (1994)42 anti-HBc+ anti-HBs 0%

(95% CI: 0% to 22%)

(0/14)

Kadian et al. (1994)42 anti-HBc+ anti-HBc 0%

(95% CI: 0% to 22%)

(0/14)

Kadian et al. (1994)42 anti-HBc+ serum HBV-DNA 0%

(95% CI: 0% to 22%)

(0/14)

De Feo et al. (2005)44,45 HBsAg-, 

anti-HBc+

HBsAg 0%

(95% CI: 0% to 6%)

(0/62)

Veroux et al. (2005)54 HBsAg-, 

anti-HBc+

HBsAg 0%

(95% CI: 0% to 32%)

(0/8)

Fong et al. (2002)55 HBsAg-, 

anti-HBc+

HBsAg 0%

(95% CI: 0% to 1%)

(2/763)

Madayag et al. (1997)56 HBsAg-, 

anti-HBc+

HBsAg 0%

(95% CI: 0% to 26%)

(0/11)

Satterthwaite et al. (1997)57 HBsAg-, 

anti-HBc+

HBsAg 0%

(95% CI: 0% to 12%)

(0/27)

Wachs et al. (1995)51 HBsAg-, 

anti-HBc IgM+

HBsAg 0%

(95% CI: 0% to 10%)

(0/34)
91

Study

Specific Test 

Results in these 

Donors

The rate applies to 

recipient positivity 

for what specific 

antigen/antibody?

Percentage of recipients 

who tested positive

(95% CI) ¶

(Number of Recipients 

Positive Post-transplant/ 

Number of Recipients 

Negative Pre-transplant)

Akalin et al. (2005)58 HBsAg-, 

anti-HBc+

anti-HBs 0%

(95% CI: 0% to 23%)

(0/13)

Madayag et al. (1997)56 HBsAg-, 

anti-HBc+

anti-HBs 55%

(95% CI: 28% to 79%)

(6/11)

Satterthwaite et al. (1997)57 HBsAg-, 

anti-HBc+

anti-HBs 11%

(95% CI: 4% to 28%)

(3/27)

Wachs et al. (1995)51 HBsAg-, 

anti-HBc IgM+

anti-HBs 0%

(95% CI: 0% to 10%)

(0/34)

Veroux et al. (2005)54 HBsAg-, 

anti-HBc+

anti-HBc 0%

(95% CI: 0% to 32%)

(0/8)

Akalin et al. (2005)58 HBsAg-, 

anti-HBc+

anti-HBc 0%

(95% CI: 0% to 23%)

(0/13)

Veroux et al. (2005)54 HBsAg-, 

anti-HBc+

anti-HBc 13%

(95% CI: 2% to 47%)

(1/8)

Fong et al. (2002)55 HBsAg-, 

anti-HBc+

anti-HBc 2%

(95% CI: 1% to 4%)

(17/763)

Madayag et al. (1997)56 HBsAg-, 

anti-HBc+

anti-HBc 9%

(95% CI: 2% to 38%)

(1/11)

Satterthwaite et al. (1997)57 HBsAg-, 

anti-HBc+

anti-HBc 7%

(95% CI: 2% to 23%)

(2/27)

Wachs et al. (1995)51 HBsAg-, 

anti-HBc IgM+

anti-HBc 0%

(95% CI: 0% to 10%)

(0/34)

Satterthwaite et al. (1997)57 HBsAg-, 

anti-HBc+

anti-HBs and 

anti-HBc

0%

(95% CI: 0% to 12%)

(0/27)

Akalin et al. (2005)58 HBsAg-, 

anti-HBc+

“HBV viremia” 0%

(95% CI: 0% to 23%)

(0/13)
92

Study

Specific Test 

Results in these 

Donors

The rate applies to 

recipient positivity 

for what specific 

antigen/antibody?

Percentage of recipients 

who tested positive

(95% CI) ¶

(Number of Recipients 

Positive Post-transplant/ 

Number of Recipients 

Negative Pre-transplant)

Miedouge et al. (2003)59 HBsAg-, 

anti-HBc+, 

serum HBV-DNAHBsAg 0%

(95% CI: 0% to 39%)

(0/6)

Miedouge et al. (2003)59 HBsAg-, 

anti-HBc+, 

serum HBV-DNAanti-HBc 0%

(95% CI: 0% to 39%)

(0/6)

Miedouge et al. (2003)59 HBsAg-, 

anti-HBc+, 

serum HBV-DNAserum HBV-DNA 0%

(95% CI: 0% to 39%)

(0/6)

HBV Transmission from HEART Transplantation

Pinney et al. (2005)60 anti-HBc+ HBsAg 4%

(95% CI: 1% to 19%)

(1/26)

Kadian et al. (1994)42 anti-HBc+ HBsAg 0%

(95% CI: 0% to 26%)

(0/11)

Pinney et al. (2005)60 anti-HBc+ anti-HBs 8%

(95% CI: 2% to 24%)

(2/26)

Tenderich et al. (2005)61 anti-HBc+ anti-HBs 48%

(95% CI: 29% to 67%)

(11/23)

Kadian et al. (1994)42 anti-HBc+ anti-HBs 18%

(95% CI: 5% to 48%)

(2/11)

Tenderich et al. (2005)61 anti-HBc+ anti-HBc 65%

(95% CI: 45% to 81%)

(15/23)

Kadian et al. (1994)42 anti-HBc+ anti-HBc 18%

(95% CI: 5% to 48%)

(2/11)

De Feo et al. (2005)44,45 HBsAg-, antiHBc+HBsAg 0%

(95% CI: 0% to 18%)

(0/18)

Ko et al. (2001)62,63 HBsAg-, 

anti-HBc+, 

anti-HBs+

HBsAg 0%

(95% CI: 0% to 28%)

(0/10)

Blanes et al. (2002)64 HBsAg-, 

anti-HBc+, 

serum HBV-DNAHBsAg 0%

(95% CI: 0% to 43%)

(0/5)
93

Study

Specific Test 

Results in these 

Donors

The rate applies to 

recipient positivity 

for what specific 

antigen/antibody?

Percentage of recipients 

who tested positive

(95% CI) ¶

(Number of Recipients 

Positive Post-transplant/ 

Number of Recipients 

Negative Pre-transplant)

Blanes et al. (2002)64 HBsAg-, 

anti-HBc+, 

serum HBV-DNAanti-HBc 0%

(95% CI: 0% to 43%)

(0/5)

Blanes et al. (2002)64 HBsAg-, 

anti-HBc+, 

serum HBV-DNAserum HBV-DNA 0%

(95% CI: 0% to 43%)

(0/5)

Blanes et al. (2002)64 HBsAg-, 

anti-HBc+, 

serum HBV-DNAlymphocyte HBVDNA

20%

(95% CI: 4% to 62%)

(1/5)

HBV Transmission from LUNG Transplantation

Hartwig et al. (2005)65 HBsAg-, 

anti-HBc+

HBsAg 0%

(95% CI: 0% to 13%)

(0/26)

Hartwig et al. (2005)65 HBsAg-, 

anti-HBc+

anti-HBc 0%

(95% CI: 0% to 13%)

(0/26)

HCV Transmission from KIDNEY Transplantation

Abbott et al. (2004)67,68 anti-HCV+ anti-HCV 9%

(95% CI: 6% to 14%)

(17/187)

Rozental et al. (2002)69 anti-HCV+ anti-HCV 25%

(95% CI: 7% to 59%)

(2/8)

Tokumoto et al. (1996)70 anti-HCV+ anti-HCV-1 33%

(95% CI: 10% to 70%)

(2/6)

Tokumoto et al. (1996)70 anti-HCV+ anti-HCV-2 60%

(95% CI: 23% to 88%)

(3/5)

Wreghitt et al. (1994)71 anti-HCV+ anti-HCV 25%

(95% CI: 7% to 59%)

(2/8)

Mendez et al. (1993)72,73 anti-HCV+ anti-HCV 6%

(95% CI: 2% to 20%)

(2/33)

Pereira et al. (1992)14,17-19 anti-HCV+ anti-HCV 91%

(95% CI: 62% to 98%)

(10/11)

Roth et al. (1992)15,20 anti-HCV+ anti-HCV 7%

(95% CI: 1% to 31%)

(1/14)
94

Study

Specific Test 

Results in these 

Donors

The rate applies to 

recipient positivity 

for what specific 

antigen/antibody?

Percentage of recipients 

who tested positive

(95% CI) ¶

(Number of Recipients 

Positive Post-transplant/ 

Number of Recipients 

Negative Pre-transplant)

Tokumoto et al. (1996)70 anti-HCV+ HCV-RNA 50%

(95% CI: 19% to 81%)

(3/6)

Wreghitt et al. (1994)71 anti-HCV+ HCV-RNA 100%

(95% CI: 65% to 100%)

(7/7)

Tesi et al. (1994)74,75 anti-HCV+, 

serum HCV-RNA+

anti-HCV 19%

(95% CI: 10% to 33%)

(8/43)

Vincenti et al. (1993)13 anti-HCV+, 

serum HCV-RNA+

anti-HCV 0%

(95% CI: 0% to 39%)

(0/6)

Tesi et al. (1994)74,75 anti-HCV+, 

serum HCV-RNA+

anti-HCV or 

indeterminate 

35%

(95% CI: 22% to 50%)

(15/43)

Tesi et al. (1994)74,75 anti-HCV+, 

serum HCV-RNA+

HCV-RNA 57%

(95% CI: 41% to 71%)

(21/37)

Vincenti et al. (1993)13 anti-HCV+, 

serum HCV-RNA+

HCV-RNA 0%

(95% CI: 0% to 39%)

(0/6)

Vincenti et al. (1993)13 anti-HCV+, 

serum HCV-RNA+

RIA 0%

(95% CI: 0% to 39%)

(0/6)

Preiksaitis et al. (1997)76 anti HCV+ and 

RIBA+

anti-HCV 62%

(95%CI 36% to 82%)

(8/13)

Preiksaitis et al. (1997)76 anti HCV+ and 

RIBA+

HCV-RNA 67%

(95% CI: 35% to 88%)

(6/9)

HCV Transmission from LIVER Transplantation

Shah et al. (1993)12,16 anti-HCV+ anti-HCV 24%

(95% CI: 11% to 43%)

(6/25)

Everhart et al. (1999)66 anti-HCV+, 

serum HCV-RNA+

anti-HCV 67%

(95% CI: 30% to 90%)

(4/6)

Everhart et al. (1999)66 anti-HCV+, 

serum HCV-RNA+

HCV-RNA 100%

(95% CI: 61% to 100%)

(6/6)

HCV Transmission from HEART Transplantation
95

Study

Specific Test 

Results in these 

Donors

The rate applies to 

recipient positivity 

for what specific 

antigen/antibody?

Percentage of recipients 

who tested positive

(95% CI) ¶

(Number of Recipients 

Positive Post-transplant/ 

Number of Recipients 

Negative Pre-transplant)

Haji et al. (2004)77-79 anti-HCV+ “detectable” antiHCV

11%

(95% CI: 4% to 27%)

(3/28)

Gudmundsson et al. (2003)80 anti-HCV+ anti-HCV 14%

(95% CI: 3% to 51%)

(1/7)

Marelli et al. (2002)81 anti-HCV+ anti-HCV 24%

(95% CI: 10% to 47%)

(4/17)

Haji et al. (2004)77-79 anti-HCV+ HCV-RNA 75%

(95% CI: 57% to 87%)

(21/28)

Gudmundsson et al. (2003)80 anti-HCV+ HCV-RNA 43%

(95% CI: 16% to 75%)

(3/7)

Marelli et al. (2002)81 anti-HCV+ HCV-RNA 12%

(95% CI: 3% to 34%)

(2/17)

Gudmundsson et al. (2003)80 anti-HCV+ liver HCV 29%

(95% CI: 8% to 64%)

(2/7)

Gudmundsson et al. (2003)80 anti-HCV+ “Any HCV infection” 43%

(95% CI: 16% to 75%)

(3/7)

File et al. (2003)34 anti-HCV+, 

serum HCV-RNA+

anti-HCV 44%

(95% CI: 19% to 73%)

(4/9)

File et al. (2003)34 anti-HCV+, 

serum HCV-RNA+

HCV-RNA 100%

(95% CI: 72% to 100%)

(10/10)

¶ The 95% confidence interval (CI) around each rate was calculated by ECRI Institute.
96

Evidence Reviews: II. Methodology to better estimate donor

infection with HIV, HBV, or HCV

Question 3. What behavioral risk factors are associated with an 

increased probability of infection with HIV, HBV, or HCV? What is the 

prevalence of these characteristics among potential solid organ donors?

And

Question 4. What nonbehavioral risk factors are associated with an 

increased probability of infection with HIV, HBV, or HCV? What is the 

prevalence of these factors among potential solid organ donors?

As most of the included studies address both Questions 3 and 4, information regarding study populations 

and protocols, study risk of bias, and our methods of analysis are reported together for both questions in 

this section. Findings regarding behavioral risk factors are reported in Question 3: Results, and findings 

regarding nonbehavioral risk factors (e.g., signs and symptoms suggestive of infection, co-morbidity,

socioeconomic factors, demographic factors) are reported in Question 4: Results.

The CDC document Guidelines for Preventing Transmission of Human Immunodeficiency Virus Through 

Transplantation of Human Tissue and Organs (1994),

100 listed seven “Behavior/History Exclusionary 

Criteria.” According to the guideline, any potential donor with any of these characteristics should not 

donate organs regardless of HIV test results:

1. “Men who have had sex with another man in the preceding 5 years.”

2. “Persons who report nonmedical intravenous, intramuscular, or subcutaneous injection of drugs 

in the preceding 5 years.”

3. “Persons with hemophilia or related clotting disorders who have received human-derived clotting 

factor concentrates.”

4. “Men and women who have engaged in sex in exchange for money or drugs in the preceding 

5 years.”

5. “Persons who have had sex in the preceding 12 months with any person described in items 1-4 

above or with a person known or suspected to have HIV infection.”

6. “Persons who have been exposed in the preceding 12 months to known or suspected HIV-infected 

blood through percutaneous inoculation or through contact with an open wound, nonintact skin, 

or mucous membrane.”

7. “Inmates of correctional systems. (This exclusion is to address issues such as difficulties with 

informed consent and increased prevalence of HIV in this population.)”

The 1994 guideline also excludes children with certain risk factors from donating, regardless of HIV test 

result status. The guideline states:
97

1. “Children meeting any of the exclusionary criteria listed above for adults should not be accepted 

as donors.

2. Children born to mothers with HIV infection or mothers who meet the behavioral or laboratory 

exclusionary criteria for adult donors (regardless of their HIV status) should not be accepted as 

donors unless HIV infection can be definitely excluded in the child as follows:

Children >18 months of age who are born to mothers with or at risk for HIV infection, 

who have not been breast fed within the last 12 months, and whose HIV antibody tests, 

physical examination, and review of medical records do not indicate evidence of HIV 

infection can be accepted as donors.

3. Children ≤18 months of age who are born to mothers with or at risk for HIV infection or who 

have been breast fed within the past 12 months should not be accepted as donors regardless of 

their HIV test results.”

The purpose of Questions 3 and 4 is to search and summarize evidence regarding potential risk factors for 

the transmission of HIV, and also HBV and HCV. Behavioral factors are presented in Question 3, and 

nonbehavioral factors are presented in Question 4. Nonbehavioral factors include signs and symptoms 

suggestive of acute or chronic infection, co-morbidity, socioeconomic factors, and demographic factors.

To be included in these questions, studies had to meet inclusion criteria, as discussed in the Introduction. 

Although data restricted to potential solid organ donors were initially sought to identify risk factors, the 

paucity of evidence motivated the inclusion of data from three additional populations: potential tissue 

donors, blood donors, and the general population. Because there was still little data on the identification 

of risk factors for HBV infection, for HBV only the criteria were expanded to include demographic and 

socioeconomic subpopulations. Such subpopulation studies may have limited enrollment to people with a 

particular ethnic heritage or occupation. Risk factors identified in these populations may not be 

generalizable to other populations, including potential solid organ donors. In addition, they cannot be 

used to determine whether the characteristic all participants were selected for is a risk factor, unless there 

is a control or comparison group in the study. 

Inclusion criteria for prevalence and incidence of identified risk factors were stricter. We did not include 

prevalence estimates from populations with pre-screened blood donors (which would underestimate 

prevalence), special demographic or socioeconomic subpopulations (which could overestimate or 

underestimate prevalence, depending on the population), or populations that over-selected for infected 

individuals in case-control study designs (which would overestimate prevalence). We also did not extract 

demographic prevalence (e.g., race or sex) or infection incidence or prevalence data (e.g., proportion coinfected) because there are other, more accurate, sources of this type of information available than the 

studies included for this question provide (such as in Question 1). Some data on the prevalence of risk 

factors appeared to overlap between Armstrong et al.30 and McQuillan et al.101, as both used NHANES IV 

(1992 to 2002) data. In these instances we used the prevalence data from Armstrong et al. because the 

data set they used was larger. No studies that assessed risk factors associated with incident infection were 

identified.

Thirty studies comprise the evidence base for Questions 3 and 4, with 22 addressing Question 3 and 

29 addressing Question 4. Of the 29 studies that associated behavioral and/or nonbehavioral risk factors 
98

with infection, 12 addressed HBV, 12 addressed HCV, and 6 addressed HIV (one study addressed both 

HBV and HCV). Twenty one studies reported identification of behavioral factors (such as drug use or 

sexual activities) and are included in Question 3. Only eight studies reported the prevalence of identified 

behavioral risk factors in potential donors or the general population, including one study that did not 

provide data for the identification of risk factors.8 (One additional study reported information on 

prevalence of risk factors from the National Health and Nutrition Examination Surveys (NHANES)-III 

(1988-1994)29 but this information was superseded by NHANES-IV (1992-2002) data from other 

studies.30,101 Twenty-nine studies reported on the identification of nonbehavioral risk factors. Of those, 

only four reported prevalence of identified factors. Although we sought information on signs and 

symptoms that may be associated with infection, extremely little information on this was identified. 

Included studies and the Questions they address are listed below in Table 27.

Table 27. Included Studies, Questions 3 and 4

Citation Year Virus(es)

Question 3 Question 4

Identification Prevalence Identification Prevalence

Potential and Actual Organ Donors

Gasink et al.102 2006 HCV   

Hidalgo et al.8 2001 Not Applicable* 

Potential Tissue Donors

Sanchez et al.103 2006 HBV   

Blood Donors

Orton et al.104 2004 HCV  

Murphy et al.105 2000 HCV  

Conry-Cantilena et al.106 1996 HCV  

Murphy et al.107 1996 HCV 

General Population

McGinn et al.108 2008 HCV 

McQuillan et al.29 1999 HBV  

Mehta et al.109 2008 HIV    

Nguyen et al.110 2008 HIV    

Zetola et al.111 2008 HIV 

Armstrong et al.30 2006 HCV    

McQuillan et al.101 2006 HIV  

Hand and Vasquez112 2005 HCV  

Nguyen et al.113 2005 HCV  

Fischer et al.114 2000 HCV  
99

Citation Year Virus(es)

Question 3 Question 4

Identification Prevalence Identification Prevalence

Alpert et al.115 1996 HIV  

Kaur et al.116 1996 HBV, HCV    

Alter et al.117 1989 HBV  

Children and Adolescents

Luban et al.118 2007 HCV 

D’Angelo et al.119 1991 HIV 

Demographic and Socioeconomic Subpopulation (HBV Only)

Lee et al.120 2008 HBV 

Tabibian et al.121 2008 HBV  

Hann et al.122 2007 HBV 

Lin et al.123 2007 HBV 

Hwang et al.124 2006 HBV  

Butterfield et al.125 2004 HBV  

Butterfield et al.126 1990 HBV  

Turner et al.127 1989 HBV  

* Hidalgo et al. assessed the prevalence of a general risk factor only (unspecified substance abuse), and did not attempt associate the factor

with any particular infection.
100

Studied Populations and Study Methods

This section provides a brief description of the enrollees and methods in the included studies. The studies 

are organized by population type (as divided in Table 27). Additional information regarding study 

protocols, including setting and location of study, method of data collection, relevant blood test used to 

determine infection status, funding source, and year(s) of data collection, are shown in Table 28. Details 

regarding participant characteristics, including methods of participant selection and selection criteria, 

demographic descriptors (e.g., percent male, race, age), are shown in Table 29.

Data on potential or actual solid organ donors were very limited. Two retrospective studies, each with few 

factors reported, were identified. Only one of those studies focused on potential solid organ donors, 

Hidalgo et al.8 This study provides reasons for donor ineligibility among a cohort of 55 potential living 

who were able to provide data regarding their health status. A second study, Gasink et al.102, statistically 

assessed the association between donor characteristics and HCV infection to indentify risk factors for 

HCV in a cohort of 10,915 actual heart donors, including 261 with HCV, using data from the Scientific 

Registry of Transplant Recipients (SRTR). Prevalence of some factors was also reported.

Potential Tissue Donors

One study on risk factors for HCV among potential cornea donors, Sanchez et al., was also included.103

Eighty three potential donors with positive serological result(s) and 56 randomly selected controls were 

included. In this study, infection status was retrospectively tested for association with behavioral and 

clinical factors in a questionnaire completed by next of kin. This study is unique in that the identification 

of risk factors relied upon next-of-kin interviews rather than medical record review or self-report. 

Actual Blood Donors

Also included were four studies that examined risk factors for HCV among actual blood donors, ConryCantilena et al.,106 Murphy et al. (2000),105 Murphy et al. (1996),107 and Orton et al.104 We included these 

studies with the intent of examining factors other than those that potential donors are screened for 

(e.g., other than men having sex with men or injection drug use). However, in all four studies, some 

donors who were followed-up with questionnaires or interviews admitted to exclusionary behaviors. 

Therefore, it was possible to investigate these factors for association with HCV. However, because 

potential donors who were not deceptive about these factors were screened out and not permitted to 

donate, we did not consider the prevalence of these factors among actual donors because the prevalence 

would be underestimated. We did not identify any studies on potential (i.e., pre-screened) blood donors, 

or potential donors who were eliminated from the donor pool as a result of the screening process.

The four studies used different approaches to identifying risk factors. Conry-Cantilena et al. and 

Murphy et al. (2000) were case-control studies that enrolled samples of infected and uninfected donors 

and compared the factors among them.105,106 Conry-Cantilena et al. enrolled 248 individuals with HCV 

and 131 without. Murphy et al. (2000) enrolled 758 infected individuals and 1,039 uninfected individuals. 

Both of these studies identified participants by retrospective assessment of their HCV status and 

prospectively collected data on risk factors using questionnaires. Orton et al. recalled blood donors who 

initially tested anti-HCV positive for further testing and collection of risk factor data and prospectively 

re-tested them using nucleic acid tests, and administered in-person questionnaires. Of those who 

completed follow-up at the time of donation, the factors of 65 participants who were confirmed as 

positive by nucleic acid tests were compared to the factors among the 225 participants who were 
101

ultimately deemed uninfected (initial false-positives). Murphy et al. (1996) was a much larger 

(n = 862,398) study that examined consecutive blood donors and retrospectively evaluated infection 

status and demographic information collected at this time of donation.107

General Population

Thirteen additional studies enrolled participants representative of a general population. By “general 

population,” we mean a population unselected for any particular demographic, occupational, or 

behavioral characteristics, or health status other than HCV, HBV, or HIV infection status. These studies

recruited participants from various settings including emergency departments,111,115 primary care 

clinics,108 medical centers,109,112,113,117 health plan enrollees,114 using advertisements to the public,116 or 

NHANES data.29,30,101,110 (When extracting data we were careful to ensure that duplicate NHANES data 

were not included. Where data from probably overlapping pools of participants were reported, we used 

the statistic from the study with the larger sample size. We only collected prevalence information from 

the most recent NHANES data.) 

The general design of these studies was to collect blood samples to test for infection and administer 

questionnaires or interviews regarding potential risk factors. Most of these studies were prospective. 

The studies were generally large, with only four enrolling under 1,000 participants. Five of these studies 

addressed HIV, five addressed HCV, and one addressed both HCV and HBV.

Children

Two included studies specifically assessed children. Luban et al. performed a record review of 2,758 

children who had received a blood transfusion and targeted factors for HCV.118 D’Angelo et al. reviewed 

records of 3,520 adolescents with leftover serum from other tests and considered factors for HIV 

infection.119

Demographic and Socioeconomic Subpopulations

A total of eight subpopulation studies that evaluated risk factors and HBV were included. Populations 

assessed in these studies include mentally ill veterans in inpatient Veterans Administration (VA) Hospital

psychiatric care,121,125 women registered for obstetric care at a military hospital,126 college students,124

embalmers,127 Asian Americans,123 and Korean-American church-goers.120,122 Most of the Asian 

Americans and Korean American church-goers were foreign-born. All of these studies were prospective. 

On the whole, these studies were smaller than the general population studies: Half enrolled fewer than 

1,000 people, with the smallest study enrolling 108 individuals.127
102

Table 28. Study Protocols for Questions 3 and 4

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

Potential and Actual Organ Donors

Gasink et al.102 2006   Hepatitis C 

Virus (HCV)

Hospitals 

– heart 

transplant 

donors

Nationwide All actual 

heart 

donations 

during time 

period

Scientific 

Registry of 

Transplant 

Recipients 

(SRTR) record 

review, including 

blood test results

Patients 

considered 

positive if 

medical chart 

marked 

“recipient antiHCV,” or 

“recipient RIBA

[recombinant 

immunoblot 

assay),” or 

“recipient RNA”

positive

No (for 

outcomes of 

interest)

Retrospective Academic 

division of 

cardiovascular 

unit. No 

disclosures 

reported.

1994 to 

2003

Hidalgo et al.8 2001  Not 

Applicable 

(prevalence 

of risk factors 

only)

Relatives 

of children 

with endstage 

renal 

disease

Brooklyn, NY Potential 

related 

donors of 

all children 

<21 with 

end stage 

renal 

disease 

(ESRD)

and 

surviving 

transplant 

between 

1990 and 

1999

Retrospective 

chart review and 

interview

Not reported 

(and not relevant 

because only 

included for 

prevalence of 

risk factors)

Not 

applicable

Retrospective Not 

reported. 

Authors 

affiliated 

with and 

data 

collected 

from 

academic 

hospital.

1990 to 

1999
103

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

Potential Tissue Donors

Sanchez et al.103 2006   All Potential 

corneal 

donors

Dallas, TX All potential 

donor 

corneas 

with 

positive 

serological 

results for 

infectious 

disease

Retrospective 

review of next-ofkin questionnaire

HIV 1/2, HIV p24

antigen (Ag), 

HIV DNA, HIV 

nucleic acid test 

(NAT), HbsAg, 

HB Core, HCV, 

HCV-NAT

No Retrospective Not 

reported. 

Authors 

affiliated 

with 

university 

medical 

centers.

2002 to 

2004

Blood Donors

Conry-Cantilena et 

al.106

1996   HCV Actual 

volunteer 

blood 

donors

Greater 

Chesapeake

and Potomac 

area

Blood 

donors to 

American 

Red Cross 

with 

positive 

EIA results, 

including 

those with 

false 

positives as 

determined 

by RIBA

Medical history 

taken by 

physician,

private drug use 

questionnaire

Enzyme linked 

immunosorbent 

assay (EIA) 1.0 

Ortho 

Diagnostics, 

EIA 2.0 Ortho 

diagnostics, 

RIBA 2.0 Chiron

Yes Prospective 

questionnaire 

of donors 

identified retrospectively by 

initial positive 

EIA result

Not 

reported. 

Most 

authors 

affiliated 

with 

National 

Institutes of 

Health.

1991 to 

1994
104

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

Murphy et al.105 2000   HCV Actual 

blood 

donors

Baltimore/

Washington, 

Southeast 

Michigan, 

Oklahoma 

City, San 

Francisco, 

Los Angeles

Cases 

were all 

HCV 

positive 

donors 

during time 

period, 

Controls by 

HCV 

negativity 

and 

matched to 

controls

Mailed 

anonymous 

questionnaire

Not reported, but 

tested through 

U.S. blood 

donation centers 

so should be 

valid

Yes Prospective 

questionnaire 

of donors 

identified retrospectively by 

initial positive 

EIA result

National 

Heart Lung 

and Blood 

Institute

1994 to 

1995

Murphy et al.107 1996  HCV Actual 

blood 

donors 

Baltimore, 

Washington 

DC, Detroit, 

Oklahoma 

City, San 

Francisco, 

Los Angeles

All 

donations 

in a time 

period

Demographic 

information 

collected at 

donation time

Secondgeneration HCV 

EIA with RIBA 

HCV 2.0 EIA 

(Abbott) or 

Matrix 

(Unlicensed) for 

confirmation

Yes Retrospective National 

Heart, 

Lung, and 

Blood 

Institute

1992 

though 

1993

Orton et al.104 2004   HCV Actual 

blood 

donors

Apparently 

nationwide

Blood 

donors to 

American 

Red Cross

Questionnaire 

administered in 

person by 

donation 

counselor or 

physician

ProCleix HIV-1 

and HCV assay 

(Chiron 

Corporation) with 

confirmation with 

RT-PCR

(reversetranscriptase 

polymerase 

chain reaction)

(NCI)

Yes Prospective 

questionnaire 

of donors 

identified retrospectively by 

initial EIA 

negative and 

NAT reactive 

result

Not 

reported, 

but 

appears to 

be 

American 

Red Cross, 

Centers for 

Disease 

Control and 

Prevention

1999 to 

2003
105

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

General Population

Alpert et al.115 1996   Human 

Immunodeficiency 

Virus (HIV)

Inner-city 

emergency 

department

Bronx, NY Consecutive adult 

noncritical 

medical 

patients

In-person 

interview by 

physician

EIA (Genetic 

systems) with 

Western blot 

confirmation 

(CambridgeBiotech)

Yes Prospective In part by 

Centers for 

Disease 

Control 

(CDC) and 

National 

Institute of 

Allergy and 

Infectious 

Diseases

1993 to 

1994

Alter et al.117 1989   HBV Cases 

reported 

to health 

department, 

controls 

from 

general 

population

Alabama, 

Washington 

State

Cases 

selected by 

reporting to 

county 

health 

department 

and had 

no known 

cause of 

hepatitis, 

Controls 

selected by 

randomly 

dialing 

other 

county 

residents

Interviews by 

nurses

HBV core 

antigen test

Yes Prospective Not 

reported, 

appears to 

have been 

publically 

funded

1985 to 

1986
106

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

Armstrong et al.30 2006   HCV General 

population

Nation-wide Participants 

in National 

Health and 

Nutrition 

Examinations 

Surveys 

(NHANES) 

IV

National Center 

for Health 

Statistics 

(NHANES) IV 

survey with 

sensitive items 

on computer

Ortho HCV 

ELISA v. 3.0 

(Ortho-Clinical 

Diagnostics); 

Repeatedly 

reactive samples 

tested with 

Chiron RIBA 

HCV Strip 

Immunoblot 

Assay v. 3.0 

(Chiron Corp). 

RIBA positive or 

indeterminate 

tested for RNA 

with COBAS 

Amplicor HCV 

Monitor Test v. 

2.0 (Roche 

Molecular 

Diagnostics)

Yes Prospective National 

Centers for 

Disease 

Control 

(CDC)

1999 to 

2002

Fischer et al.114 2000   HCV HMO 

enrollees

Twin Cities 

metro area of 

Minnesota

Health plan 

patients 

identified 

as being at 

elevated or 

normal risk 

though 

database 

(plus health 

care 

workers)

Anonymous risk 

profile 

questionnaire

Polymerase 

chain reaction 

(PCR)

Yes Prospective Contract 

with 

Integrated 

Therapeutic 

Group of 

ScheringPlough

1996 to 

1997
107

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

Hand and 

Vasquez112

2005   HCV General 

population

Patients at 

university 

medical 

center

Patients 

who had 

HCV test 

and 

positive 

(case) or 

negative 

(control) 

results

Interview in 

person in 

hospital setting 

or by telephone 

if not available 

in person

Abbott HCV EIA 

2.0

Yes Prospective 

interview based 

upon 

retrospective 

review of lab 

results

State of 

Texas 

Tobacco 

Settlement 

Endowment for 

Texas Tech 

University 

Health 

Sciences 

Center

2000 to 

2002

Kaur et al.116 1996   Hepatitis B 

Virus (HBV), 

HCV

General 

population

Nationwide, 

primarily 

urban

Volunteers 

responding 

to 

advertisement

Risk profile 

questionnaire. 

Details not 

reported.

HbsAg and 

anti-HBC (Abbott 

Diagnostics) and 

HCV EIA 2.0 

(Abbott 

Laboratories) 

confirmed by 

MATRIX HCV 

dot-blot 

immunoassay 

(Abbott 

Laboratories)

Yes Prospective Schering 

Pharmaceuticals, 

Abbott 

Laboratories, 

American 

Liver 

Foundation

1992

McGinn et al.108 2008  HCV Adult 

primary 

care clinic

Inner city 

New York, 

NY

Random 

selection

Survey by in 

person interview 

and medical 

record review 

HCV EIA 2.0 

Recombinant 

c100-3, HC31, 

and HC-34, 

(Abbott 

Laboratories)

No (only 

univariate 

used)

Prospective No 

disclosures 

reported

2002 to 

2003
108

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

McQuillan et al.101 2006   HIV General 

population

Nationwide Participants 

in National 

Health and 

Nutrition 

Examinatio

ns Surveys 

(NHANES) 

versions 

1988 to 

1994 and 

1999 to 

2002

Confidential 

surveys

ELISA (Genetic 

Systems, or 

OrganonTeknika 

Corporation) and 

confirmed by 

Western blot 

(Biotech/DuPont) 

or HIV-1/HIV-2 

peptide EIA 

(Genetic 

Systems) 

confirmed by 

Western blot 

(Calypte 

Biomedical 

Corporation) or 

urinalysis 

(Calypte HIV01 

Peptide EIA 

confirmed by 

Western blot 

(Calpype 

Biomedical)

No (ECRI 

Institute 

calculated 

univariate 

analyses)

Prospective Federal 1999 to 

2002 for 

risk 

factors
109

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

McQuillan et al.29 1999   HBV General 

population

Nationwide Participants 

in National 

Health and 

Nutrition 

Examinations 

Surveys 

(NHANES)

Confidential 

surveys

NHANES II 

Antibody to HBV 

surface antigen 

or core antigen 

and HBV surface 

antigen by EIA 

(AUSAB, 

CORZYME, 

AUSZYME, 

Abbott)

NHANES III HBC 

core antibodies 

radioimmunoassay 

(CORAB) and 

confirmation by 

surface antigen 

and surface 

antigen antibody 

(AUSRIA and 

AUSAB, Abbott)

Yes Prospective Not 

specifically 

stated. All 

authors 

employed 

by National 

Center for 

Infectious 

Diseases, 

Centers for 

Disease

Control 

(CDC)

1976 

through 

1994
110

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

Mehta et al.109 2008   HIV Hospital 

urgent 

care 

center, 

inpatient 

floors, 

outpatient 

primary 

care, nonclinical 

drop-in 

center, 

emergency

department

Boston, MA Consecutive (all) or 

selfselected for 

HIV test, 

depending 

on setting 

where 

sample 

was drawn 

from

Personal 

interview in 

medical center

OraQuick Rapid 

HIV-1 Antibody 

Test (Orasure 

Technologies) 

with confirmation 

by both ELISA 

and Western blot

No Retrospective Public 

health 

department 

and CDC

2002 to 

2004

Nguyen et al.110 2008   HIV General 

population

New York 

City

Random 

selection 

from NYC 

households

In-person 

interview plus 

computerassisted survey 

for sensitive 

information

Unnamed 

HIV-1/HIV-2 EIA 

with Western blot 

confirmation, 

Remnants tested 

for HIV-1 RNA 

by PCR.

No Prospective CDC 2004

Nguyen et al.113 2005   HCV General 

internal 

medicine 

clinic 

(controls) 

and hepatology 

clinic 

(cases) 

at urban 

medical 

university 

Philadelphia, 

PA

Not 

reported

Anonymous 

written 

questionnaire

HCV antibody 

(Home Access 

Health Corp, 

Hoffman 

Associates)

Yes Prospective In part by 

ScheringPlough; 

no financial 

disclosure

Not 

reported
111

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

Zetola et al.111 2008  HIV Patients 

in general 

hospital 

emergency 

department

San 

Francisco, 

CA

Emergency 

department 

patients 

who had 

blood 

drawn and 

were not 

known to 

be HIV+

Record review of 

demographic 

and medical 

records

All screened by 

EIA (Genetic 

Systems HIV1/HIV-2 plus O 

EIA, Bio-Rad 

Laboratories); 

positives 

confirmed with 

immunofluoresce

nt assay (IFA) 

(Fluorognost 

HIV-1 IFA, 

Sanochemia 

Pharmazeutika 

AG), and 

discordant 

results resolved 

with RNA 

transcription 

mediated 

amplification test 

(TMA Aptima 

HIV-1 RNA 

Quantitative 

Assay, GenProbe Inc.)

Yes Retrospective Division of 

Research 

Resources 

of National 

Institutes of 

Health 

(NIH), 

California 

HIV 

Research 

Program 

Grant, 

San Francisco 

Department 

of Health

2007
112

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

Children and Adolescents

Luban et al.118 2007  HCV Tertiarycare 

urban 

university 

childrens’

hospital 

and 

community 

controls

Washington, 

D.C.

Record 

identificatio

n of 

children 

who had 

blood 

transfusion

Record review Abbott anti-HCV 

EIA with 

confirmation by 

Chiron RIBA-2 

and COBAS 

AmpliCore HCV 

PCR test

No Retrospective NIH Transfusi

ons 

administer

ed 

between 

1982 and 

1992

D’Angelo et al.119 1991  HIV Children’s 

National 

Medical 

Center

Washington, 

D.C.

Leftover 

serum from 

other tests

Record review Abbott EIA, 

DuPont Western 

Blot and another 

EIA for 

confirmation

No Retrospective Not 

reported, 

authors 

either 

affiliated

with a 

university 

hospital or 

federal 

health 

agency

1987 to 

1989
113

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

Demographic and Socioeconomic Subpopulations (HBV only)

Butterfield et al.125 2004   HBV Veterans 

Administration 

(VA) 

psychiatric 

inpatient 

unit

Durham, NC Consecutive 

admissions

Standardized inperson risk 

interview 

Abbott Corzyme 

test for HBV core 

antibody

Yes Prospective VA 

research 

grants

1998 to 

2000

Butterfield et al.126 1990   HBV Women 

registered 

for 

obstetric 

care at 

military 

hospital

El Paso, TX Consecutive 

enrollment

Questionnaire at 

initial physician 

consultation 

AUSRIA II-125 

radioimmunoassay 

kit, Abbott

No Prospective Not 

reported

1987 and 

1988

Hann et al.122 2007  HBV KoreanAmerican 

churchgoers

Northeastern 

U.S.

Recruited 

from 

church

Questionnaire 

completed by 

family (no highly 

sensitive or 

personal 

information)

HbsAg, anti-HBs, 

HbeAg, anti-HBe 

tests by Abbott

No Prospective Not 

reported

1988 to 

1990

Hwang et al.124 2006   HBV College 

students

Houston, TX Recruited 

from large 

classes of 

required 

courses 

and public 

areas of 

universities

Anonymous selfadministered 

questionnaire

Abbott anti-HBc, 

anti-HBs, and 

HbsAg

Yes Prospective CDC 1999
114

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

Lee et al.120 2008  HBV KoreanAmerican 

churchgoers

Colorado Recruited 

from 

church

Collection of 

demographic 

data and 

vaccination 

history

HBsAg, antiHBs, brand 

unspecified but 

run on Advia 

Centaur XP 

immunoassay 

system

No Prospective University 

school of 

nursing 

research 

grant, 

Shil-IL 

Overseas 

Korean 

Health 

Foundation, 

Equality 

Fund from 

Colorado 

Trust

2004 to 

2007

Lin et al.123 2007  HBV Recruited 

Through 

advertise

ments 

and 

screened 

at 

community-based 

events

San 

Francisco bay 

area

None 

reported 

other than 

AsianAmerican 

and signed 

informed 

consent

Questionnaire 

about 

demographic 

information and 

vaccination 

history

HBsAg, plus in 

some cases, 

HBs, brands 

unspecified

Yes Prospective Not 

explicitly 

reported, 

possibly 

Asian Liver 

Center at 

Stanford 

University

2001 

through 

2006

Tabibian et al.121 2008   HBV Veterans 

acutely 

and 

voluntarily 

hospitalized in 

psychiatric ward

West

Los Angeles

Consecutive 

admissions

Interview using 

standardized 

questionnaire, 

VA risk 

assessment tool 

HbsAg, HBsAb, 

HbcAg, brands 

unspecified

Yes Prospective Not 

reported

2002 to 

2003
115

Citation Year

Question 

3

Question 

4

Virus(es)

Setting(s) 

Selected 

From Location

Selection 

Methods

Method of Risk 

Factor Data 

Collection

Relevant Blood 

Test Used

Clearly 

States 

Adjusted / 

Controlled 

Statistics 

Reported

Prospective or

Retrospective Funding

Year(s) 

Data 

Collected

Turner et al.127 1989   HBV Embalmers in an 

urban 

area

Boston and 

Worcester 

MA metropolitan areas

Not 

reported

Oral 

questionnaire

HBV surface 

antigen and 

antibody and 

core tests using 

Abbott brand 

tests. 

Confirmation by 

Western blot

Yes Prospective Biomedical 

research 

grant from 

National 

Institutes of 

health and 

National 

Institute for 

Occupation

al Health 

and Safety

1986 to 

1987
116

Table 29. Participant Characteristics for KQ 4 and 5

Citation Year KQ4 KQ5 Virus(es)

Participant 

Selection Selection Criteria

Number of 

Participants

Percent 

Male

Race (as reported 

in study) Age

Potential and Actual Organ Donors

Gasink et al.102 2006   Hepatitis C 

Virus (HCV)

Actual heart 

donors registered 

in Scientific 

Registry of 

Transplant 

Recipients

All heart donors of 

transplant recipients 

at least 18 years who 

received their 

transplant between 

4/1/1994 and 

7/31/2003

18,618 

initially 

considered 

eligible, 

10,915 met 

inclusion 

criteria, 

261 with 

HCV+ donor

69% White: 86%;

Black: 12%;

Other: 2%

Median: 

29 years

Hidalgo et al.8 2001  Not 

applicable 

(prevalence 

of risk 

factors only)

Potential living 

donor parents of 

child transplant 

candidates

Potential related 

donors of all children 

<21 years with endstage renal disease 

and surviving 

transplant between 

1990 and 1999

55 potential 

donors 

screened

36% Race of potential 

donors not 

reported. Their 

children transplant 

candidates were:

Black: 60%

Hispanic: 30%

Caucasian: 7%

Asian: 3%

Mean: 

38.8 years

Potential Tissue Donors

Sanchez et al.103 2006   All All donor corneas 

with positive 

serological 

results for 

infectious disease 

plus negative 

controls

Consecutive tissues 

with positive 

serological results in 

time period

83 donors 

with positive 

serological 

results plus 

56 randomly 

selected 

seronegative 

controls

62% White: 75%;

Black: 17%;

Other: 4%

Mean: 

54 years
117

Citation Year KQ4 KQ5 Virus(es)

Participant 

Selection Selection Criteria

Number of 

Participants

Percent 

Male

Race (as reported 

in study) Age

Blood Donors

Conry-Cantilena et 

al.106

1996   HCV Blood donors with 

positive enzyme 

linked 

immunosorbent 

assay (EIA) 

enrolled 

consecutively 

until target 

enrollment 

attained

Consecutive 

volunteer whole 

blood donors who 

donated between 

1991 and 1994 and 

had positive EIA

4,585 donors 

screened 

positive, 

481 of them 

enrolled. 

248 enrolled 

as positive 

and 131 as 

negative 

(and 102 

indeterminate)

57% Black: 12.7% Mean: 

40 years

Murphy et al.105 2000   HCV All HCV positive 

and during time 

period and 

matched HCV 

negative blood 

donors

By serostatus; 

cases and controls 

matched by age, sex, 

race/ethnicity, 

first time vs. 

repeat donor status

2,316 HCV+ 

invited, 758 

participated. 

2,316 HCVinvited, 1039

participated

54% White nonHispanic: 73%,

Black nonHispanic: 10%,

Hispanic: 8%,

Asian: 2%,

Other: 2%

Most aged 30 

to 49 years

Murphy et al.107 1996  HCV All blood donors Consecutive blood 

donors

862,398 53% White: 81%,

Black: 7%,

Hispanic: 6%,

Asian: 3%, 

Other: 1%, 

Missing: 2%

Majority 

between 20 

and 49 years,

Range: 

11 to 93 years
118

Citation Year KQ4 KQ5 Virus(es)

Participant 

Selection Selection Criteria

Number of 

Participants

Percent 

Male

Race (as reported 

in study) Age

Orton et al.104 2004   HCV Blood donors 

anti-HCV- but 

unconfirmed 

nucleic acid test 

(NAT) reactive 

results

Blood donors antiHCV- but 

unconfirmed reactive 

NAT results who 

donated blood in time 

period and completed 

questionnaire 

810 potential 

participants, 

of whom 116 

confirmed 

positive. 

65 cases and 

225 controls 

completed 

study.

54% 88% White nonHispanic, rest 

“other”

Mean: 

39 years

General Population

Alpert et al.115 1996   Human 

Immunodefi

ciency Virus 

(HIV)

Consecutive 

noncritical adults 

in emergency 

department

Consecutive 1,744 

patients, with 

988 having 

blood drawn 

and 875 with 

adequate 

amount for 

testing and 

no known 

HIV

Not 

reported 

(NR)

NR NR
119

Citation Year KQ4 KQ5 Virus(es)

Participant 

Selection Selection Criteria

Number of 

Participants

Percent 

Male

Race (as reported 

in study) Age

Alter et al.117 1989   HBV Cases reported to 

county health 

department, 

controls selected 

randomly

Cases had acute 

HBV infection and 

none of the following 

factors within last 

six months: 

blood transfusion, 

IV drug use, 

male homosexual 

activity, health care 

employment requiring 

frequent contact with 

blood, hemodialysis, 

sexual or household 

contact with HBV 

carrier. Controls were 

HBV-uninfected and 

were matched by 

age within 5 years, 

sex, race, area code, 

and telephone 

exchange.

76 cases, 

152 controls

Not 

reported

Not reported Not reported

Armstrong et al.30 2006   HCV Nationally 

representative 

sample of 

civilians and noninstitutionalized 

population

Selected to be 

representative of 

general population

21,509 

eligible,

17,548 

interviewed, 

and 

15,079 gave 

sufficient 

blood sample 

and were 

included

48% Non-Hispanic 

White: 40%;

Non-Hispanic 

Black: 23%;

MexicanAmerican: 29%

NR
120

Citation Year KQ4 KQ5 Virus(es)

Participant 

Selection Selection Criteria

Number of 

Participants

Percent 

Male

Race (as reported 

in study) Age

Fischer et al.114 2000   HCV Health plan 

patients identified 

as being at 

elevated or 

normal risk 

though database, 

(or health care 

workers, not 

included in this 

analysis).

Based upon 

diagnostic codes 

suggestive of 

Hepatitis C, 

plus controls without 

any liver-related 

diagnoses

8,800 

identified in 

database. 

1,380 total 

completed 

study, 

including 

454 at higher 

risk and 

926 controls. 

34% NR NR, 26% less 

than 50 years

Hand and

Vasquez112

2005   HCV Clinic or hospital 

patients selected 

by HCV test 

result

For cases, positive 

HCV test, for 

controls, negative 

HCV test. Patients 

were tested due to 

suspected liver 

disease, planned 

hemodialysis, or 

hepatitis risk factors 

People who 

participated in 

interview could be 

included.

627 70% Hispanic: 87%,

Non-Hispanic: 

13%

Mean age:

45.5, 

Range: 14 to 

99

Kaur et al.116 1996   Hepatitis B 

Virus (HBV), 

HCV

Volunteers 

responding to 

advertisement

None reported 8581 42% White: 77%,

African American: 

14%,

Asian: 3%,

Other: 6%

Mean:

45 (Standard 

error [SE] 15) 

years
121

Citation Year KQ4 KQ5 Virus(es)

Participant 

Selection Selection Criteria

Number of 

Participants

Percent 

Male

Race (as reported 

in study) Age

McGinn et al.108 2008  HCV A stochastically 

randomized 

sample of all 

patients attended 

primary care 

were invited to 

participate 

Age 18 or older, 

English or Spanish 

language proficient

1,485 invited, 

1,000 

enrolled

27% Latino: 54%;

Black: 32%;

White: 10%;

Other: 4%

Mean:

50.1 (SD: 14.7) 

years

McQuillan et al.101 2006   HIV “Stratified multistaged probability 

cluster design 

that selected a 

sample 

representative of 

the U.S. civilian 

noninstitutionalized 

population.”

Participants aged 18 

to 59 who were 

anonymously tested 

for HIV antibody

NHANES III: 

15,141 

participants 

total, 13,022 

agreed to 

interview, 

11,203 

agreed to 

exam and 

had sufficient

serum

NHANES 99-

’02:

6,458 invited, 

5,926 agreed 

to exam and 

had HIV test

NR NR NR

McQuillan et al.29 1999   HBV Stratified, 

multistage, 

probability cluster 

design of U.S.

households

Random selection Analysis of 

risk factors 

“generally 

restricted” to 

NHANES III, 

which 

enrolled 

40,000 

people

NR NR NR
122

Citation Year KQ4 KQ5 Virus(es)

Participant 

Selection Selection Criteria

Number of 

Participants

Percent 

Male

Race (as reported 

in study) Age

Mehta et al.109 2008   HIV Consecutive 

patients in 

hospital system 

were approached 

for participation 

All patients who 

consented

17,594 

pretest 

counseling 

sessions and 

16,750 HIV 

tests, 

229 new HIV 

diagnoses

59% Black: 39%;

White: 23%;

Hispanic: 19%;

Haitian: 8%

Median age: 

36 years

Nguyen et al.110 2008   HIV Random 

selection or 

representative 

households of 

adults aged 

at least 20 years

Not institutionalized 

or homeless

4,026 

randomly 

selected, 

3,388 

screened, 

3,047 eligible, 

1,999 

completed 

interview and 

at least one 

component of 

physical 

exam, and 

1,626 

provided 

blood

46.2% White: 30%

Black: 21%

Asian: 13%

Hispanic: 36%

Mean age NR; 

57.3% at least 

40 years old

Nguyen et al.113 2005   HCV Patients with

known HCV 

under care at 

hepatology clinic 

(cases) and 

asymptomatic 

patients with 

unknown status 

in general 

medical clinic 

(controls) 

Aged 18 to 60 years

English proficient

429 total, 

225 HCV 

positive; 

204 HCV 

negative

42% White: 63%;

African-American: 

27%;

Asian: 4%;

Latino: 3%;

Other: 3%

NR; wide 

range of 

decades of 

birth
123

Citation Year KQ4 KQ5 Virus(es)

Participant 

Selection Selection Criteria

Number of 

Participants

Percent 

Male

Race (as reported 

in study) Age

Zetola et al.111 2008  HIV All patients 

seeking 

emergency 

medical attention 

who had blood 

drawn and were 

not known to be 

infected with HIV

Consecutive patients 1,820 had 

blood drawn, 

1,674 were of 

unknown or 

negative HIV 

status and 

met inclusion 

criteria

62.3% White: 27.4%,

Black: 28.4%,

Latino: 22.6%,

Other: 17.6%,

Unknown: 4%

Mean: NR,

24.9%

18-30 years, 

29.1%

31-45 years, 

44.1%

>45 years

Children and Adolescents

Luban et al.118 2007  HCV Children who had 

blood or blood 

product 

transfusions

Under 15 years at 

time of transfusion, 

no perinatal 

transmission, and 

no malignancy, 

hemophilia, 

rheumatologic 

disease, HIV, or 

organ or marrow 

transplantation or 

dialysis

5,473 

identified as 

potentially 

eligible, 

4,726 

locatable, 

2,758 tested

59% African-American: 

38%,

Asian: 1.5%,

Caucasian: 48.3%,

Hispanic: 3.4%,

Other/unknown: 

8.8%

NR, age at 

time of 

transfusion 

less than 

one year on 

average

D’Angelo et al.119 1991  HIV Children 

attending 

ambulatory care 

hospital services 

with leftover 

serum 

Appears to be all 

children with leftover 

serum 

3,520 33% NR Mean NR, 

all patients 

20 years and 

younger
124

Citation Year KQ4 KQ5 Virus(es)

Participant 

Selection Selection Criteria

Number of 

Participants

Percent 

Male

Race (as reported 

in study) Age

Demographic and Socioeconomic Subpopulations (HBV only)

Butterfield et al.125 2004   HBV Inpatients in 

Veterans 

Administration

(VA) psychiatric 

unit

Consecutively 

admitted veterans 

with severe mental 

illness who were 

either African 

American or 

Caucasian and had 

blood test results

399 

consecutive 

recruits, 376 

included

90% Caucasian: 41%,

African-American: 

59%

NR

Butterfield et al.126 1990   HBV Consecutive 

women seeking 

prenatal care

All patients included 1,466 0% NR NR

Hann et al.122 2007  HBV Korean-American 

church-goers

None reported 

besides participant 

selection method

6,130 48% Korean-American: 

100%

NR

Hwang et al.124 2006   HBV College students For HBV risk 

assessment, U.S. or 

Canada born and 

no evidence of 

immunization

7,960, of 

whom 4,328 

were U.S. or 

Canada born 

and had no 

evidence of 

immunization

39.2% Non-Hispanic 

white: 41.5%,

non-Hispanic 

black: 26.1%, 

Hispanic: 22.2%,

Asian: 6.8%,

Other :3.5%

Median age: 

21 years

Lee et al.120 2008  HBV KoreanAmericans 

attending church 

Adult, literate KoreanAmericans (18 to 70 

years old) willing to 

sign informed 

consent

609 46% Korean-American: 

100%, 

98% of adults born 

in Korea

Mean age: 

49 years

Lin et al.123 2007  HBV Asian Americans Adults (at least 

18 years old) willing 

to sign informed 

consent

3,279 tested. 

3,163 

included

39.7% Asian Americans: 

100%, 

93.4% born in Asia

Median age: 

52.9 years
125

Citation Year KQ4 KQ5 Virus(es)

Participant 

Selection Selection Criteria

Number of 

Participants

Percent 

Male

Race (as reported 

in study) Age

Tabibian et al.121 2008   HBV Voluntarily 

admitted veteran 

psychiatric 

inpatients

Consecutive 

voluntary admissions 

with consent

234 

admissions, 

with 129 

participants

98% Caucasian: 50.3%,

African-American: 

33.3%,

Hispanic: 9.3%,

Other, including 

Asian and 

Native American: 

7%

Mean age: 

48.9 years 

(SD: 8.9 years)

Turner et al.127 1989   HBV Have embalmed 

more than 

20 bodies

Not reported 108 NR NR NR
126

Analysis Methods

We extracted all data on the identification of risk factors from the included literature, including factors 

that were investigated but not found to be associated with infection. For Question 3 these data are 

presented in Table 33 (HBV), Table 34 (HCV), and Table 35 (HIV). For Question 4 these data are shown 

in Table 39 (HBV), Table 40 (HCV), and Table 41 (HIV). We grouped the extracted data by category as

listed in the 1994 CDC document Guidelines for Preventing Transmission of Human Immunodeficiency 

Virus Through Transplantation of Human Tissue and Organs100, and qualitatively summarized the 

evidence for each of the risk factors listed in the guideline by describing which studies identified 

associations for which infection in which population type. Following that, in the same manner we 

summarized the evidence for additional risk factors not listed in the 1994 guideline. Information on 

behavioral risk factors is presented first (Question 3), followed by information on nonbehavioral factors 

(Question 4). 

We performed the analysis qualitatively (i.e., using narrative descriptive analysis) because the 

methodologic and reporting differences among the studies made combining them in quantitative analysis 

(i.e., meta-analysis) inappropriate. These fundamental between-study differences fell into four main 

categories:

1. Population: We included data from organ, tissue and blood donors, as well as from general 

populations drawn from various settings, and, for HBV, various special subpopulations

2. Outcomes: Potential risk factors were often reported in different ways. For instance, studies used 

different numbers to define “multiple” sex partners or gathered data regarding different time 

spans (i.e., lifetime drug use, drug use within past 6 months).

3. Comparators: Some studies used different bases of comparison. For instance, in assessing 

whether MSM is a risk factor, one study compared the prevalence of infection in MSM to 

heterosexual men, and another compared it to the prevalence of infection among men who have 

never had sex.

4. Analysis type: Although use of various metrics can be dealt with in secondary quantitative 

analysis, most of these studies differed with respect to whether univariate or multivariate analyses 

were used. Some reported one but not the other. Data reporting methods did not provide sufficient 

information to make standardization possible. Not having information on both clouds the 

independence of the relationship between the factor of interest and the infection in question, 

especially since data from various populations were considered. For more information on this, 

please see the following text.

We considered data calculated in two main ways, through univariate analyses and multivariate analysis. 

Univariate analyses look at the association between the factor of interest and infection. These may be the 

only type of analysis performed in a study, or it may be the first step in identifying which potentially 

important factors should be included in the multivariate model. Multivariate models look at the 

association between the factor of interest and infection while taking into consideration additional 

confounding factors. This is the type of analysis required to determine if the risk factor is an independent

risk factor. This is important because many of the behavioral risk factors are found together in 

individuals. For instance, among individuals who have been incarcerated, is exposure during incarceration 

itself or the illicit activity that led to incarceration (e.g., sex work, drug use) that is the true risk factor? 
127

Demographic and socioeconomic factors are not risk factors in and of themselves but proxies for other 

risk factors. On the other hand, dependent factors identified by univariate analyses may be useful for 

identifying at-risk potential donors. To provide as much information as possible about these factors, we 

extracted information on both univariate and multivariate analyses where both were provided. Where 

ECRI Institute calculated effect sizes and p-values, unadjusted univariate analyses were performed by 

necessity because that is what the reported data permits. 

Assessment of Risk of Bias (Quality of Study Design): Identification of Risk Factors

To assess the risk of bias of the included studies, we asked the questions listed in Table 30. (Itemized 

quality assessment for each study for both questions is provided in Table 31.) Following Table 30

we provide a discussion of each of the quality domains assessed.

Table 30. Risk of Bias Assessment Items for Questions 3 and 4: Identification of 

Risk Factors

Domain

Question 

Item Question

Comparability of 

uninfected and 

infected 

participants

Identification 

(I)-A

Were infected and uninfected participants similar on other risk 

factors?

I-B If not, were statistical adjustments performed to control for other 

risk factors?

Validity of risk 

factor data 

collection

I-C Was risk factor data collected in a valid manner (e.g., confidential 

or anonymous collection of sensitive risk factor data, collection of 

personal information from the person directly instead of someone 

else)?

Validity of method 

used to determine 

infection status

I-D Was infection status determined accurately? (i.e., accuracy of 

diagnostic test method used to determine infection status)

Comparability of Uninfected and Infected Participants (Quality Items I-A and I-B)

Regarding item A, none of the studies were uninfected and infected groups of participants similar on all 

risk factors besides the one being investigated at the time (most studies investigated multiple factors). 

That is, infected and uninfected participants differed in many ways. Therefore, none of the studies can be 

considered to satisfy these items. However, many of the studies did perform statistical adjustments to 

control for confounding factors. Whether controlled or adjusted analyses were performed for each study is 

reported in the table of study protocols (Table 28), in the data extraction tables, and in the text of the 

results section.

Although not all studies met items A or B, all of these studies drew all of their participants from a single 

pool, either selecting them from the pool based upon their infection status or including all participants in 

the pool and subdividing them by infection status.
128

Validity of Risk Factor Data Collection (Quality Item I-C)

Much of the data collected for Question 3, regarding behavioral risk factors, is very private and highly 

sensitive. Much of these data also pertain to illicit activity. Therefore, to promote reliable reporting of risk 

factor data, confidentiality and anonymity are preferable. Although not all studies went to great pains to 

ensure privacy (e.g., anonymous questionnaires, interview given through computer interface only), all of 

the included studies for Question 4 offered confidentiality, at the very least within the context of medical 

care. In addition, because behavioral risk factors are nearly always personal matters, the most reliable 

information will come from the individual about him or herself. 

Although objective record and database reviews are generally regarded as being more reliable than patient 

interview, most types of information of interest, especially behavioral risk factors, are unlikely to be 

catalogued in such records. The applicability of these interview and questionnaire self-report data to 

potential solid organ donors is unclear, since most solid organ donors are deceased. 

Data on deceased actual organ donors in Gasink et al. were collected from a registry and record review, 

but most of the items inquired about were not highly sensitive, and this is unlikely to compromise the 

integrity of their findings. However, sensitive data for Sanchez et al. was collected from next of kin of 

deceased potential tissue donors. Findings from Sanchez et al. suggest that next-of-kin may be unaware of 

(or unwilling to report) important factors including high-risk sexual activities, or history of sexually 

transmitted infection (STI). Although the data in Sanchez et al. were not verified against objective 

records, it is unlikely that the prevalence of these items was actually zero, as the next-of-kin reported. 

The next-of-kin data in Sanchez et al. may be inaccurate. This was the only study that did not satisfy 

quality item c.

Although not all studies that only addressed Question 4 appear to have explicitly offered confidentiality, 

most of these studies investigated factors that are less sensitive (e.g., country of birth, race, age) and so it 

is unlikely that the validity of the findings will be affected, and this should not be considered a threat to 

the validity of Question 4.

Validity of Infection Status Determination (Quality Item I-D)

In accord with the general inclusion criteria for this review, the infection status of all participants had to 

be determined using objective laboratory testing methods. The validity of infection status determination 

therefore is based upon the accuracy of diagnostic test used (see Table 28 for which test(s) were used in 

each study; nearly all studies reported it). Most studies confirmed antibody or antigen tests with more 

specific methods such as Western blot, nucleic acid tests, or immunoblots. These studies should have 

fewer false positives than studies that did not confirm positives. On the whole, the validity of infection 

status determination is good. Studies nearly universally used reputable commercially-available diagnostic 

tests. No studies relied upon rapid or oral tests or home brew (i.e., noncommercial, unregulated) tests 

alone. Only one study, Nguyen et al., used a test with potentially compromised accuracy. In this study, 

participants were given a kit to take home and test themselves with. Although the test may be accurate 

with appropriate use, because the test was not administered under supervision and were not verified with 

follow-up testing, it is not possible to be as confident in the results.

Itemized quality assessment for each of the studies is shown in Table 31, below.
129

Table 31. Quality Assessment for Questions 3 and 4: Identification of Risk Factors

Study Year

Question 3 Question 4

I-A I-B I-C I-D I-A I-B I-C I-D

Potential and Actual Organ Donors

Gasink et al.102 2006   

Hidalgo et al.8 2001   Not applicable

Potential Tissue Donors

Sanchez et al.103 2006  

Blood Donors

Conry-Cantilena et al.106 1996      

Murphy et al.105 2000      

Murphy et al.107 2000 Not applicable   

Orton et al.104 2004      

General Population

Alpert et al.115 1996      

Alter et al.117 1989      

Armstrong et al.30 2006      

Fischer et al.114 2000      

Hand and Vasquez112 2005      

Kaur et al.116 1996      

McGinn et al.108 2008 Not applicable  

McQuillan et al.101 2006    

McQuillan et al.29 1999      

Mehta et al.109 2008    

Nguyen et al.110 2008    

Nguyen et al.113 2005    

Zetola et al.111 2008 Not applicable   

Children and Adolescents

Luban et al.118 2007 Not applicable  

D’Angelo et al.119 1991 Not applicable  
130

Study Year

Question 3 Question 4

I-A I-B I-C I-D I-A I-B I-C I-D

Demographic and Socioeconomic Subpopulations (HBV only)

Butterfield et al.125 2004      

Butterfield et al.126 1990    

Hann et al.122 2007 Not applicable  

Hwang et al.124 2006      

Lee et al.120 2008 Not applicable  

Lin et al.123 2007 Not applicable   

Tabibian et al.121 2008      

Turner et al.127 1989      

A checkmark () means that the study met the quality criterion for this Question; the lack of a checkmark means that 

the study either did not meet the criterion, or it was unclear whether the study met the criterion. The criteria specific to 

this Question were:

3/4 I-A. Was the population potential solid organ donors?

3/4 I-B. For other populations, was the population unselected (i.e., not based on demographic or behavioral

characteristics)? Were infected and uninfected participants similar on other risk factors?

3/4 I-C. If not, were statistical adjustments performed to control for other risk factors?

3/4 I-D. Was risk factor data collected in a valid manner (e.g., confidential or anonymous collection of sensitive 

risk factor data, collection of personal information from the person directly instead of someone else)

3/4 I-E. Was infection status determined accurately? (i.e., accuracy of diagnostic test method used to determine 

infection status)
131

Assessment of Risk of Bias (Quality of Study Design): Prevalence of Risk Factors

To assess the risk of bias of the included studies, we used the same quality assessment instrument as was 

used in Question 1. One modification was made for the third item. Rather than ask about the accuracy of 

determining infection status, we ask about the accuracy of determining the prevalence of the risk factor. 

Specifically, highly personal information should be reported by the person in question. Ideally, medical 

history (e.g., history of STD) would be collected using objective data, but we considered subject selfreport acceptable as well. Studies meeting 2 or 3 criteria were not penalized for quality in the GRADE 

system. Studies meeting only 0 or 1 criterion were penalized one level.

Table 32. Quality Assessment for Questions 3 and 4: Prevalence of Risk Factors

Study Year

Question 3 Question 4

P*-A P-B P-C P-A P-B P-C

Potential Organ Donors

Hidalgo et al.8 2001    Not applicable

Actual Organ Donors

Gasink et al.102 2006 - -  Not applicable

General Population

Armstrong et al.30 2006 -   -  

Kaur et al.116 1996 -   -  

McQuillan et al.101 2006 -   Not Applicable

Mehta et al.109 2008 -   -  

Nguyen et al.110 2008 -   -  

*P: Prevalence

A checkmark () means that the study met the quality criterion for this Question; the lack of a checkmark means that 

the study either did not meet the criterion, or it was unclear whether the study met the criterion. The criteria specific to 

this Question were:

3/4 P-A. Was the population potential solid organ donors?

3/4 P-B. For other populations, was the population unselected (i.e., not based on demographic or behavioral

characteristics)? (studies of potential solid organ donors were scored as Yes, because they enrolled 

the population of interest)

3/4 P-C. Was risk factor prevalence determined accurately? (i.e., were personal factors reported by subject 

themselves?)
132

GRADE Assessment of Identification of Risk Factors

To assess the strength of the evidence regarding the identification of risk factors, we applied a GRADE 

system modified for this purpose. We assigned GRADE ratings for evidence bases comprised of at least 

two studies addressing a certain factor, divided by virus. The steps used to assign a rating are described in 

this section. The GRADE table for Question 4 is Table 36, and the table for Question 5 is Table 42, which 

appear following the results sections.

Because all of these studies are observational, they were all assigned a starting grade of “Low,” per 

convention. The following factors could be used to decrease this grade: Overall quality, consistency, 

directness, and precision. Large magnitude of effect could be used to increase one grade. Criteria for these 

are provided in the following text. If a direct relationship between infection and the factor was suggested 

(e.g., higher number of sex partners associated with higher odds of infection), the GRADE was increased 

by one. Explanation of all plausible confounders could also increase the GRADE. These steps are 

described in the following subsections. We did not assess publication bias.

Overall Risk of Bias

Overall quality was determined in two steps. First, each study was assessed for risk of bias, as shown in 

Table 31. Then, the overall risk of bias of the evidence base was determined using the median number of 

quality items. Evidence bases with a median of 3 or 4 criteria were considered “moderate,” those with a 

median of 2 criteria were considered “low,” and those with only 1 criterion were considered “very low.”

Evidence bases with a “very low” quality rating were decreased by one grade.

Consistency

Consistency was determined based upon how well the qualitative findings of the studies agreed with each 

other. If studies were consistent with the exception of a special population study or a very low-quality 

study; or if all studies (two or more) had large magnitudes of effect (OR>5) with the exception of one 

study, the evidence base was still considered consistent because these studies are least reliable. Other 

inconsistency that was easily explained for a single reason (with no other possible explanation) would not 

be downgraded. Evidence bases with only one study were downgraded due to lack of demonstrated 

consistency, because scientific replication is an important component of evidence.

Directness

Only one study8 examined potential organ donors, and this was a very small study of living relative 

donors, who comprise the minority of potential donors. One study on actual heart donors that did not 

exclude donors with HCV was included.102 Although a large number of donors were examined in this 

study, it is not possible to determine how highly selected they were (i.e., how many potential donors were 

excluded and for what reasons) because these data are not reported.

Most of the remaining studies studied potential tissue donors, actual blood donors, or members of the 

general population. These studies were not downgraded due to indirectness, despite the fact that they 

did not enroll potential organ donors. This is because the identification of a risk factor in these 

populations may be generalizable to potential organ donors. By contrast, studies of demographic and 

socioeconomic subpopulations are probably not very representative of potential organ donors. Some of 

the populations have high prevalence of multiple high-risk behaviors and a relatively high prevalence of 
133

HBV (e.g., psychiatric inpatient veterans with co-morbid substance abuse problems), while others had 

few high-risk behaviors and a relatively low prevalence of HBV (e.g., women receiving prenatal care). 

We therefore downgraded evidence bases that predominately had this type of study (i.e., -1).

Precision

We considered all evidence bases with three or more studies to be precise (and therefore did not 

downgrade for imprecision). When there were only two studies, we considered the factor precise if one of 

two criteria were met. We considered the evidence base precise if both effects were statistically 

significant. If this criterion was not met, we evaluated the evidence base for precision by combining the 

two studies’ data in a summary effect size and evaluating the confidence intervals around the point 

estimate. We considered the evidence base precise if the confidence intervals were sufficiently narrow,

defined as a maximum difference of 0.4 between the estimated log odds ratio and the upper bound of its

95% confidence interval. For example, if the summary effect size was 1.1 with a 95% CI from 0.86 to 1.4, 

this was deemed sufficiently precise (because ln(1.4)-ln(1.1) is less than 0.4), whereas if the summary 

effect size was 1.1 with a 95% CI from 0.6 to 2.0, this was considered imprecise (because ln(2)-ln(1.1) is 

greater than 0.4, and the evidence is consistent with important effects in either direction). When there was 

only a single study, we considered the evidence base precise if either the effect was statistically 

significant, or if the confidence interval around the effect size was sufficiently narrow (defined in the 

same way as with two studies).

Large Magnitude of Effect

We upgraded the rating for any evidence base in which the studies consistently showed a large magnitude 

of effect. We defined this as any statistically significant odds ratio with a point estimate of 2.0 or higher. 

We did not require that the confidence intervals around the effect size point estimate be fully above 2.0.

Dose-Response Association

Evidence of a dose-response association is suggested if increasing levels of the factor corresponded to 

increasing risk of infection. Although studies could have measured such outcomes using continuous 

reporting (e.g., total number of lifetime sex partners), in this evidence base studies measured a risk factor 

on a categorical basis. For example, Nguyen et al. (2005)

113 examined the risk factor of number of 

lifetime sex partners by placing each respondent into one of five categories: 0, 1, 2-9, 10-49, or 50+. 

If the risk of infection increased along with the number of sex partners, we considered this a doseresponse association. We upgraded some evidence bases +1 where the dose-response association was 

clear multiple studies.

Significant Association Found Despite Confounders

If the studies in an evidence base found a factor to have a statistically significant relationship with 

infection despite the fact that the evidence base was clearly biased against finding such a relationship, 

we upgraded +1 GRADE Assessment of Prevalence of Risk Factors

GRADE Assessment of Prevalence of Risk Factors

To assess the prevalence of behavioral and nonbehavioral risk factors, we used the system described in 

Question 1.
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Question 3: Results

The results on identification of risk factors are presented in this section. Information pertinent to the 

exclusionary factors listed in the 1994 guideline is presented first, and then information regarding 

additional factors is presented. Text was prepared for all factors that were reported by at least two studies. 

All of the data used to produce this section is provided in Table 33 (HBV), Table 34 (HCV), Table 35

(HIV), and Table 37 (prevalence of factors), which follow the text.

Exclusionary Behavioral Criteria from 1994 Guideline

The following sections present all data identified as relevant to the exclusion criteria from the 1994 

guideline. Specifically, we did not restrict the information provided to original timeframes (e.g., engaged 

in a particular behavior “within 5 preceding years,” “currently” incarcerated.). We also included 

additional very relevant information in these sections, such as sex partners not identified in the original 

guideline.

Men Who Have Sex with Men

The 1994 guideline excludes from donating “Men who have had sex with another man in the preceding 

5 years.” We identified zero studies that inquired whether men engaged in sex with other men (MSM) in 

this particular time frame. However, several studies addressed lifetime history of having sex with other 

men. Briefly, two studies found associations with HBV, two did not find associations with HCV, and two 

studies found an association with HIV.

HBV: In a sample of men aged 17 to 59 years drawn from the general population, McQuillan et al. 

compared the prevalence of HBV among men who reported having sex with other men to those who did 

not and found a significantly increased prevalence of HBV among MSM.29 Hwang et al. compared HBV 

infection rates among MSM compared to men who have never had sex in a population of college students 

and found that the rate of HBV was higher among MSM in both univariate and multivariate analyses.124

HCV: Murphy et al. (2000) compared HCV prevalence between homosexual or bisexual men to men who 

had never had sex among blood donors and did not find an increased prevalence when the comparison 

was controlled for intravenous drug use (IDU). However, the unadjusted risk was elevated.105 Hand and 

Vasquez compared the rates of HCV among MSM and non-MSM among adults tested for HCV because 

of clinical suspicion and did not find a significant difference in a univariate analysis.112

HIV: McQuillan et al. reported the prevalence of HIV among MSM to non-MSM in a sample drawn from 

the general population (using NHANES data), and the unadjusted rate shows MSM have a significantly 

higher prevalence of HIV.101Using New York City (NYC) HANES data from a later year, Nguyen et al.110

also found a significantly higher rate of HIV among MSM in a univariate analysis.

GRADE Summary: The evidence associating MSM with HBV and HIV was moderate. For both the 

evidence bases consistently found an association, and the magnitude of the effect was large. However, the 

strength of evidence associating MSM with HCV infection in blood donor and general populations 

studies was very low due to inconsistent findings. Neither pertinent study found MSM to be an 

independent risk factor for HCV (although MSM may be an important proxy factor; the evidence is 

insufficient to tell).
135

Prevalence: Reported prevalence of MSM in the included studies were 3.7%101 and 9.3%.110

GRADE Summary of Prevalence: The evidence for the prevalence data was rated as low due to 

indirectness and inconsistency.

Injection Drug Users

The 1994 guideline excludes from donating “Persons who report nonmedical intravenous, intramuscular, 

or subcutaneous injection of drugs in the preceding 5 years.” We identified zero studies that investigated 

the risk of injection drug use (IDU) within this time frame. Most identified studies associated lifetime 

IDU with infection, and one considered the association with IDU greater or less than 6 months before the 

blood draw. Some studies reported IDU, and others reported intravenous drug use (IVU). In general, 

studies did not report both or distinguish between the two. Briefly, IDU/IVU was associated with HBV by 

three studies but not in a fourth (the fourth study being a smaller study of a special obstetric population), 

HCV in seven studies, and HIV in two of three studies.

HBV: Kaur et al. associated IDU with HBV in a multivariate analysis of volunteers from the general 

population.116 Tabibian et al.121 and Butterfield et al. (2004)125 identified an increased risk of HBV among 

IVU veterans in inpatient psychiatric hospitals, and Hwang et al. identified an increased risk of HBV

among IDU college students.124 Butterfield et al. (1990)126 did not find an elevated risk in an obstetric 

population. However, it appears that this is probably due to the low prevalence of HBV and IDU in this 

population. Only one individual in the population reported IDU, and she was HBV negative. Rather than 

contradict the association between IDU and HBV, the study was probably underpowered to detect an 

association given the low prevalence of both in this special low-risk subpopulation.

HCV: Among blood donors, Orton et al.104 and Murphy et al.105 detected an association between IDU and 

HCV, and Conry-Cantilena et al.106 detected an association between IVU and HCV. Orton et al., use 

within the last six months only was associated with infection.104 Among people in a study group drawn 

from the general population, an increased prevalence of HCV was associated with IDU in Armstrong et 

al.,30 Fischer et al.,114 and Hand and Vasquez,112 and with IVU in Kaur et al.116

HIV: McQuillan et al.101 studied IDU and the national general population, and Nguyen et al.110 assessed 

ever having used a needle for drugs, and in univariate analyses both found an increased rate of HIV. 

Mehta et al.109 did not find an association between IDU and HIV among hospital patients; the reason for 

this is unclear.

Two studies specifically investigated the association between infection and injection steroid use, and 

neither found any association. Hwang et al. did not detect an increased risk of HBV among college 

students who injected steroids,124 and Orton et al. did not find an increased risk of HCV among blood 

donors.104 However, the Orton study did find a trend toward higher infection rate among blood donors 

who had injected steroids longer than six months ago (P = 0.07), and a larger study might detect an 

association. 

GRADE Summary: The strength of the evidence associating IDU with HCV was “moderate” due to the 

consistently large effect sizes found in all studies that associated this factor (with the exception of one 

small study on steroid use only that did not find an association with infection). For HBV, the evidence 

was “low.” All but one special population study found an association, but not all of the studies found a 
136

large magnitude of effect (not including the findings of one study that injection steroid use was not 

associated with HBV). For HIV, the evidence was “low.”

Prevalence: Prevalence of injection drug use reported in the general population studies were 1.4%,110

1.7%,30 3.5%,116 and 7.9%.109 Of the IDUs in one of those studies, 63.2% reported that they did not use a 

needle exchange program.109

GRADE Summary of Prevalence: The prevalence data for injection drug abuse was rated as low due to 

inconsistency and indirectness.

Related Factors: In addition, reporting living with an IDU was associated with HCV among blood 

donors, even when IDU was controlled for,105 as was living with an IDU in the last six months.104

Alter et al. grouped household and sexual contact with an IDU during the last six months and found it was 

associated with recent HBV infection in a univariate, but not multivariate, analysis.117 Among the general 

population, both being at a social gathering with injection drugs and witnessing the use of injection drugs 

were associated with HCV.113 See the section High Risk Sex Partners for information on infection risk 

among people who have sex with IDUs.

We also identified information on other types of substance abuse. For information, under Risk Factors 

Identified in the Literature as of 2009 see “Non-injection substance use and abuse.”

Sex Work

The 1994 guideline excludes from donating “Men and women who have engaged in sex in exchange for 

money or drugs in the preceding 5 years.” We did not find any literature that studied the association 

between this factor and the given time frame, but we did find literature that studied lifetime sex work and 

infection risk. Briefly, sex work was not associated with HBV in three studies (one was the next-of-kin 

tissue donor interview study, the other two enrolled special subpopulations of psychiatric inpatient 

veterans) or with HIV in one study (the next-of-kin interview study) but was associated with HCV in 

three studies.

HBV: In their study of tissues donors, Sanchez et al. did not find any association between sex work and 

infection with HBV upon univariate analysis. However, their data came from next-of-kin interviews, and 

none of the relatives of infected potential donors reported sex work.103 Among psychiatric inpatient 

veterans, Tabibian et al.121 did not detect an association between “sex bartering” in a multivariate 

analysis. In that population rates of sex bartering were high among both HBV negative (30%) and HBV 

positive (37%) participants. Unprotected sex for drugs was not associated with HBV infection upon 

multivariate analysis in the other study that enrolled psychiatric inpatient veterans, Butterfield et al. 

(2004).125

HCV: Sanchez et al. did not find any association between sex work and infection with HBV among tissue 

donors, with sex work as reported by next of kin.103 Sex work was associated with HCV among blood 

donors in Murphy et al. in a multivariate analysis105 and in general populations studies by Hand and 

Vasquez112 and Nguyen et al. in univariate analyses.113 (In Hand and Vasquez, all women who reported 

sex work also reported IDU.)
137

HIV: In the study of tissues donors, Sanchez et al. did not find any association between sex work and 

infection with HIV.103

GRADE Summary: The evidence relating sex work and HBV and HIV infection was rated as very low. 

For HBV this was due to indirectness; the data were from primarily special populations. For HIV, this 

was due to having only one study of very low quality. In the HBV and HIV studies, no relationship was 

detected. For HCV, the evidence was rated as low. Three studies found associations. A fourth study 

did not, but we did not downgrade the evidence due to inconsistency because it was of very poor quality.

Prevalence: One study reported the prevalence of exchanging sex for drugs or money among patients in 

an urban medical care center at 2.3%.

109

GRADE Summary of Prevalence: The prevalence of sex work was rated as low due to indirectness and 

lack of proof of consistency.

High-Risk Sex Partners

The 1994 guideline excludes from donating “Persons who have had sex in the preceding 12 months with 

any person described in items 1–4 above [refers to MSM, IDU, sex workers, and people with clotting 

disorders, who are covered in Question 4] or with a person known or suspected to have HIV infection.”

We did not identify any literature on infection risk in people with high-risk sex partners during this time 

frame, but we did identify literature on infection risk associated with having high-risk sex partners at 

some point in life. As the scope of this evidence report encompasses HBV and HCV in addition to HIV, 

we have also included data on infection risk among people having sex with a person with known or 

suspected hepatitis. Briefly, having a high-risk or infected sex partner was associated with HBV in six of 

seven studies (the seventh being a special subpopulation study of psychiatric inpatient veterans), with 

HCV in ten studies, and with HIV in one study. 

Sex with IDU

HBV: Sex with an IDU was associated with HBV in general population groups (including when use of 

IDU was controlled for) by Kaur et al.116 and in univariate analyses among college students by Hwang et 

al.,124 but not among psychiatric inpatient veterans in Tabibian et al.121 Sex or household contact with an 

IDU was associated with HBV infection in Alter et al.117 upon univariate investigation, but not when use 

of IDU was controlled for. 

HCV: Sex with an IDU or IVU was found to be associated with HCV in blood donors by Murphy et al. 

(2000)105 in univariate analysis and Orton et al.,104 in multivariate analysis, and in the general population 

by Nguyen et al.113 in univariate analysis and Kaur et al.116 in multivariate analysis. In Orton et al. the 

time frame was limited to the six months prior to donation.

GRADE Summary: The evidence associating HBV infection with having a sex partner who uses injection 

drugs was rated as very low due to inconsistent findings. For HCV, the evidence was moderate due to the 

consistent findings of association with large magnitude of effect.

Prevalence: In one study, 5% of respondents reported having sex with an IDU.116
138

GRADE Summary of Prevalence: The evidence of prevalence of having an IDU sex partner was low due 

to indirectness and lack of proof of consistency. 

Sex with a Sex Worker

HBV: Sex with a sex worker was not associated with HBV among psychiatric inpatient veterans in a 

univariate analysis in Tabibian et al.121

HCV: Sex with a sex worker was associated with HCV among blood donors in a multivariate analysis in 

Murphy et al.105 and in univariate analyses of general population studies by Ngyuen et al.113 and Hand and 

Vasquez.112 However, in Hand and Vasquez the relationship was no longer significant in the multivariate 

analysis.

GRADE Summary: A single special population study did not associate HBV with sex with a sex worker, 

but this evidence is rated as “very low” due to indirectness and lack of proof of consistency of evidence. 

Three studies associated having sex with a sex worker with HCV in univariate analyses. This evidence 

was rated as “very low.” 

Prevalence: In one study, 7.4% of respondents indicated they had had sex with a sex worker.109

GRADE Summary of Prevalence: The estimate of prevalence of having sex with a sex worker was graded 

as low due to indirectness and lack of proof of consistency.

Sex with People Known to Have Infection

HBV: Sex with a partner with hepatitis was found to be a risk factor for HBV in college students in 

Hwang et al.,124 but not in an obstetric population in Butterfield et al. (1990).126 Both of these analyses 

were univariate.

HCV: Among blood donors, sex with someone with hepatitis at any point in life in Murphy et al. (2000)105

in a multivariate analysis, or during the last six months in Orton et al.104in a univariate analysis, was 

associated with HCV. 

HIV: Having sex with someone known to have HIV was associated with having HIV by Mehta et al. in a 

group of patients from a general population using univariate analysis.109

GRADE Summary: The evidence associating HBV and having a sex partner with a known infection was 

rated as very low due to low quality, inconsistency, and indirectness. The evidence associating the factor 

with HIV was also rated as low, for having no proof of consistency but a large effect size magnitude. For 

HCV the evidence was rated as low for consistently identifying sex with people known to have infection

as a risk factor for HCV.

Prevalence: On study stated that 3.6% of participants reported having sex with someone known to be 

infected with HIV.109

GRADE Summary of Prevalence: The estimate of prevalence of having sex with someone known to be 

HIV-positive was graded as low due to indirectness and lack of proof of consistency.

Other High-Risk Sex Partners
139

Some miscellaneous types of high-risk sex partners pertinent to high-risk sex partners not mentioned in 

the original guideline were also reported. Sexual promiscuity (defined as history of STD, sex with a sex 

worker, or at least five sex partners per year) was associated with HCV infection in blood donors in 

Conry-Cantilena et al.106 Alter et al. did not associate HBV infection with sex with a blood transfusion 

recipient, with a health care worker, or a person with a foreign birth in an endemic area.117 Sex with a 

transfusion recipient was associated with HCV in blood donors in Murphy et al.105 We report these other 

high-risk sex partners here because they are germane to the larger issue of having high-risk sex partners. 

However, we did not grade this evidence because these factors were reported by one study only.

Inmates

The 1994 guideline excludes from donating “Inmates of correctional systems. (This exclusion is to 

address issues such as difficulties with informed consent and increased prevalence of HIV in this 

population.)” No studies that examined the association between present incarceration and infection were 

identified. However, the searches did identify studies that examined the association between recent or 

lifetime history of incarceration. In brief, a history of incarceration was associated with HBV in three of 

four studies, with HCV in four of five studies, and was not associated with HIV in one study. The study 

that did not detect an association of incarceration and HBV, HCV, or HIV infection was Sanchez et al., 

the tissue donor study based upon information provided by next of kin.

HBV: A history of incarceration as reported by next-of-kin was not associated with HBV in potential 

tissue donors in Sanchez et al.103 In general population studies, imprisonment within the last six months 

was associated with recent HBV infection in a univariate analysis, but not a multivariate analysis in Alter 

et al.117 Incarceration was also associated with HBV upon univariate analysis among psychiatric inpatient 

veterans in Tabibian et al.121 and among college students incarcerated for at least 24 hours in Hwang et 

al.124

HCV: A history of incarceration as reported by next-of-kin was not associated with HCV infection in 

potential tissue donors in Sanchez et al.103 Incarceration was associated with HCV in three studies of 

blood donors, Orton et al.,104 Murphy et al. (2000),105, and Conry-Cantilena et al.106 Two of those studies 

also tested whether incarceration was an independent risk factor; in both of those studies incarceration 

was associated with IDU. Murphy et al. (2000) found that incarceration for more than three days was an 

independent risk factor (although, compared with the unadjusted odds, odds were not as large once IDU 

was controlled for in the multivariate model),105 while Conry-Cantilena et al. found that, once adjusted for 

IDU, it was not.106 In addition, having been arrested was associated with HCV infection in a general 

population sample by Nguyen et al.113

HIV: A history of incarceration as reported by next-of-kin was not associated with HIV infection in 

potential tissue donors in Sanchez et al.103

GRADE Summary: Aside from one very low-quality study, a history of incarceration was consistently 

associated with HCV, and rated as low in strength overall. The association with HBV was inconsistent 

due to conflicting findings, and the association with HIV is unclear because only one very low-quality 

study addressed this outcome. The ratings for HBV and HIV were therefore both very low.

Risk Factors in Children
140

We identified no literature on any behavioral risk factors in children, or on the risk of infection from 

mothers who engage in those risk behaviors. While vertical transmission is generally recognized as a 

mode of hepatitis or HIV transmission, this body of literature lacks the evidence to assess the 1994 

criteria as risk factors. This may be because of the relative infrequency of this mode of transmission, and 

because of the lack of data on children. For instance, although they used NHANES data from the general 

nationwide population, Armstrong et al. reported identifying only three people under the age of 20 years 

that were infected with HCV, which precluded the investigation of risk factors in children and adolescents 

in their study.30 In the literature base analyzed in this report, only one individual, a 17-year-old first-time 

blood donor with HCV RNA but not anti-HCV, had perinatal exposure as a possible mode of 

transmission.104 Her mother had an HCV infection during her pregnancy, and no other likely causes 

exposure were identified.

Additional Potential Risk Factors Identified in the 2009 Literature Search

In addition to the factors identified in the 1994 guideline, we extracted data on all other reported 

behavioral risk factors identified in the literature and describe the findings regarding factors reported by 

at least two studies.

Other Sex Practices

Multiple Partners

Having multiple partners, including heterosexual partners, was associated with increased risk of infection 

across different populations. In brief, various measures of having multiple partners were associated with 

HBV in five studies, with HCV in six studies, and with HIV in one of three studies.

HBV: HBV infection was associated with sex with multiple partners in general populations in Kaur et al.116

in multivariate analysis. In multivariate analyses, multiple partners within the last six months was 

associated with recent HBV infection in a general population in Alter et al.117 and among psychiatric 

inpatient veterans in Butterfield et at. (2004).125 In a sample of people representative of the general 

population, compared to individuals with zero or one lifetime sex partners, having at least two lifetime sex 

partners was associated with HBV in McQuillan et al. in a multivariate analysis, and the odds of infection 

increased with greater numbers of partners.29 Among college students in the study by Hwang et al., both 

having at least 50 lifetime heterosexual partners and having at least 5 heterosexual partners in the preceding 

four months were associated with HBV infection in univariate analyses.124

HCV: HCV infection in women blood donors was associated with having at least 11 male sexual partners 

(compared to having zero sexual partners) in Murphy et al. (2000)105 in multivariate analysis. Having the 

same number of lifetime female partners among men was not associated with HCV in the same study. 

Having two or more sexual partners, whether same sex or not, in the last six months was associated with 

an increased rate of HCV infection overall in Orton et al.104 in a univariate analysis. In general population 

univariate analyses, HCV was also associated with having “frequent” sex partners in Fischer et al.,114

“multiple” sex partners in Kaur et al.,116 and at least 20 sexual partners in Armstrong et al.30 Greater 

numbers of sex partners was also associated with HCV infection in Nguyen et al.113 Hand and Vasquez 

noted the strong association between greater numbers of sex partners and IDU in their study. Of the 

18.5% of their patients who reported having at least 10 sex partners in their sample, 84% also reported 

IDU.112
141

HIV: In the general population, having multiple sex partners in the past year was not associated with HIV 

in Nguyen et al.,110 nor was having at least 10 lifetime sex partners in Mehta et al.109, but having 50 or 

more lifetime sex partners was associated with HIV in McQuillan et al.101 All of these analyses were 

univariate.

GRADE Summary: Studies used different thresholds to define “multiple sex partners,” (ranging from as 

few as 2 to as many as 50 or more) so identifying the minimum number of partners associated with an 

increased risk of infection is not possible based upon this evidence base. However, using their various 

definition, HBV and HCV studies did (with the exception of heterosexual men in one HCV study) 

consistently associate infection with having multiple sex partners. For HBV and HCV, the strength of this 

association was moderate due to a positive “dose” response association. For HIV there was also a doseresponse relationship in two studies (one study found a relationship with having at least 50 partners, the 

other did not find a relationship with having at least 10 partners). The third study did not find a 

relationship with having “multiple” sex partners in the past year. The evidence was rated as low for 

having a dose-response relationship but inconsistent findings.

Prevalence: In a national general population, 29% of survey respondents indicated having had at least 10 

sex partners,30 and 3.5% reported having at least 50 sex partners.101 Among New Yorkers, 6.6% reported 

at least 50 sex partners.110 22% of New Yorkers reported having sex with multiple partners during the 

previous year,110 and 26% of volunteers from an urban area reported sex with multiple partners.116

GRADE Summary of Prevalence: Prevalence estimates of having “multiple” sex partners (number 

undefined) and having at least 2 sex partners (but not more than 49 in one study) were both rated as 

moderate due to indirectness. The prevalence of having at least 50 partners was rated as low due to 

indirectness and lack of consistency.

Same-Sex Partners, Not Restricted to Men

Three studies investigated having same sex partners but did not restrict the analysis to MSM. Two 

associated this factor with HCV, and the other associated it with HIV.

HCV: Having same-sex partners among women was associated with an increased risk of HCV among 

women blood donors in Murphy et al. (2000)105 in multivariate analysis. For women who had had only 

one same-sex partner, this risk was no longer significant when adjusted for IDU, but it remained 

significant if there were two or more same-sex partners. Among outpatients, Nguyen did not find any 

association between having sex with a person of the same sex and HCV infection.113

HIV: Mehta et al. detected a univariate association between having a same-sex partner and HIV, including 

both men and women in the sample.109

GRADE Summary: The evidence for HCV was rated as very low due to inconsistency and imprecision. 

The evidence for HIV was rated as low because the single study had large magnitude of effect but could 

provide no proof of consistency for the evidence base.

Prevalence: One study asked both men and women if they had same-sex sex partners, and 8.2% reported 

that they did.109
142

GRADE Summary of Prevalence: This evidence was rated as low due to indirectness and lack of proof of 

consistency.

Age at First Sexual Intercourse

Younger age at the time of first sexual experience was also associated with infection among adults in 

univariate analyses. One study associated it with HBV, two associated it with HCV, and one associated it 

with HIV.

HBV: Age of 18 years or younger was not associated with HBV in McQuillan et al. (1990) in a 

multivariate analysis.29 Age at first intercourse of 15 years or younger was associated with HBV infection 

among college students in Hwang et al. in a univariate analysis.124

HCV: In the general population, age of 17 years or younger was associated with HCV in Armstrong et al.

in a univariate analysis. The study stratified age at first intercourse by age younger than 11, age 12-15, 

and age 16-17 years. The groups of people who were younger at the time of their first sexual intercourse 

had the highest risk of HCV.30

HIV: Age of 18 years or younger was associated with HIV in McQuillan et al. (2006) in a univariate 

analysis. The size of this effect was large.101

GRADE Summary: For HBV, one study associated HBV with age at first intercourse 15 or younger, and 

another did not find a relationship with age at first intercourse 18 or younger. This evidence was rated as 

low because, although the findings were not necessarily consistent, they do suggest a ‘dose-dependent’ 

relationship between younger age at first intercourse and increased risk of HBV. For HCV, one study 

found that younger age was associated with infection in a dose-dependent relationship, and the evidence 

rating for it was ‘low.’ For HIV, age younger than 18 was associated with increased risk of infection, and 

the evidence for this was rated as ‘low’ for having a large magnitude of effect despite no proof of 

consistency.

Prevalence: The proportion of adults who reported having sex at age 18 or younger were 58%30 and 

59%101 in two studies.

GRADE Summary of Prevalence: This estimate was rated as moderate due to lack of directness to 

potential organ donors.

Additional Various Associations

We report additional reported associations between sexual practices and infection below because they are 

relevant to this overall section. However, we did not assign Grade ratings because these factors were 

reported by so few studies.

• Unprotected sex was associated with HCV infection in a general population by Fischer et al.114, 

although not using condoms consistently was not associated with HIV infection in a general 

population by Mehta et al.109 or Nguyen et al.110

• Anal-insertive sex that occurred at least six weeks ago was associated with HIV infection among men 

in a general population, and anal-receptive sex at least six weeks ago among women and men in a 

general population in Mehta et al.109
143

• Having vaginal sex was associated with a reduced risk in HIV compared with people who did not have 

vaginal sex (but may have been having anal sex) in the general population study by Mehta et al.109

Non-injection Substance

Other Illicit Drugs

Of the studies that inquired about the association between non-injection illicit drug use (mostly inhaled 

drugs, predominantly intranasal cocaine), two of five found an association with HBV and seven of eight 

found an association with HCV. Two of the studies that did not find an association with HBV both enrolled 

a special subpopulation (psychiatric inpatient veterans). The other study that did not find an association 

with either HBV or HCV was the next-of-kin interview study of tissue donors, Sanchez et al.103

HBV: Illicit drug use was not associated with HBV in the tissue donor study by Sanchez et al.103 Ever 

having used cocaine was associated with HBV in the general population by McQuillan et al.29 in a 

multivariate analysis. HBV infection was associated with intranasal drug use among the college students 

in Hwang et al.124 However, in Tabibian et al.121 and Butterfield et al.125, who enrolled psychiatric 

inpatient veterans, HBV infection was not associated with inhaled or ‘snorted’ drugs. 

HCV: Any illicit drug use was not associated with HCV in the tissue donor study by Sanchez et al.103

Intranasal drugs were associated with HCV infection in blood donors in Orton et al.,104 Conry-Cantilena 

et al.106 and Murphy et al.105, including when adjusted for IDU or other factors in two of those studies 

(the third study did not perform adjusted analyses.

104 In a general population, use of snorting or inhaling 

nonprescription drugs,113 inhaling cocaine,114 using intranasal cocaine,112 and use of non-injection drugs 

other than marijuana30 were all associated with increased prevalence of HCV. Two of the studies 

investigated whether this factor was independently associated with HCV, and Armstrong et al. found it 

was using NHANES data30 while Hand and Vasquez found it was not based upon a smaller set of data on 

adults tested for HCV because of clinical suspicion.112 However, Hand and Vasquez note that cocaine use 

in the absence of IDU or tattoos was unusual in their sample. Although 39% of patients admitted to 

intranasal cocaine, only 2% of whom did not have tattoos or IDU used cocaine. 

Being at a social gathering with cocaine was associated with HCV in Nguyen et al.113 Having friends who 

use “street drugs” was associated with an increased risk of HCV among blood donors Orton et al.104

HIV: HIV was associated with ever using cocaine or street drugs in a univariate analysis by McQuillan et 

al. (2006)101 and in a multivariate analysis by Alpert et al.

115 among members of the general population.

GRADE Summary: The evidence associating non-injection illicit drug use and HBV was inconsistent and 

graded as “very low” due to this inconsistency. Aside from one very low-quality study, studies 

consistently associated non-injection drug use with HCV. The evidence associating HCV with noninjection drugs was rated as low. Two studies associated HIV with non-injection drug use, and this 

evidence was rated also rated as low.

Prevalence: Among potential living organ donors in one smaller study, 5.5% reported having ongoing 

drug abuse problems.8 In the general population, 17% reported lifetime use of drugs other than 

marijuana,30 18% reported ever having used street drugs,110 and 21% reported using street 

drugs/cocaine.

101
144

GRADE Summary of Prevalence: The estimate of ongoing drug use prevalence in living potential organ 

donors was rated as low due to imprecision and lack of proof of consistency. The estimates of drug use in 

the general population were rated as moderate due to indirectness.

Alcohol

The association between alcohol intake and infection was less consistent. 

HBV: Alcohol use, as reported by next-of-kin, was not associated with HBV infection among potential 

tissue donors in a univariate analysis in Sanchez et al.103 HBV was not associated with alcohol use 

disorder among psychiatric inpatient veterans in Butterfield et al. in a multivariate analysis (2004).

125

HCV: HCV was associated with “heavy” alcohol use in heart donors in Gasink et al.102, and with having 

at least two units of alcohol per day among adults tested for HCV because of clinical suspicion in Hand 

and Vasquez.112 However, HCV was not associated with alcohol use among tissue donors in Sanchez et 

al.,103 having at least 5 alcoholic drinks weekly in patients in Nguyen et al.113 or alcoholism in HMO 

enrollees in Fischer et al.114 All of these analyses were univariate.

HIV: HIV was associated with having an alcohol and/or (unspecified) drug problem among HMO 

enrollees in Fischer et al.114 (as identified in a claims database), but not with alcohol use among potential 

tissue donors in Sanchez et al.103 Both of these analyses were univariate.

GRADE Summary: Alcohol use was not associated with HBV and was inconsistently associated with 

HCV and HIV. These evidence bases were all rated as “very low” due to inconsistency and/or 

imprecision.

Prevalence: In a database study of actual organ donors, 20% reportedly drank heavily.102

GRADE Summary of Prevalence: The estimate of heavy alcohol abuse was rated as low due to low study 

quality and lack of proof of consistency. The directness to potential donors is also unclear.

Tobacco

HBV: No association was found between cigarette smoking and HBV among tissue donors in the study by 

Sanchez et al.103

HCV: A history of tobacco use was associated with HCV in heart donors in Gasink et al.,102 and cigarette 

smoking was associated with HCV (but not HBV or HIV) in tissue donors in Sanchez et al.103 Both of 

these associations were made using univariate analyses. 

HIV: The same tissue donor study that did not find an association between cigarette smoking and HBV or 

HCV also did not find one between cigarette smoking and HIV.103

GRADE Summary: One organ donor study associated tobacco with HCV, but the tissue donor study did 

not; the strength of the evidence base as very low. For HBV and HIV the evidence was rated as very low 

because only one study that did not find a relationship was identified.

Prevalence: Among actual heart donors, 36% had a history of tobacco use.102
145

GRADE Summary of Prevalence: The estimate of tobacco use was rated as low due to low study quality 

and lack of proof of consistency. The directness to potential donors is also unclear.

Tattoos and Piercing

Tattoos and piercings were not associated with HBV in any of five studies or with HIV in one study, but 

tattoos were associated with HCV in six studies and piercings were associated with HCV in three of six 

studies. We report on tattoos and piercing because the tissue donor study, Sanchez et al.103 reported on 

them together.

HBV: Tattoos, piercing, and acupuncture (as collectively analyzed as one outcome and reported by nextof-kin) were not associated with HBV in tissue donors in Sanchez et al.103

Tattoos were not associated with HBV infection among psychiatric inpatient veterans in Tabibian et al.,121

women receiving prenatal care in Butterfield et al. (1990),126 or among college students in Hwang et al.,124

unless the college students were tattooed with reused non-autoclaved needles. Having a tattoo in the last 

six months was not associated with acute HBV infection by Alter et al.117

Piercings were not associated with HBV among psychiatric inpatient veterans in Tabibian et al.121, and 

body piercings (other than ears) were not associated with HBV among college students in Hwang et al.124

Piercings within the last six months were not associated with acute HBV in the general population either 

in Alter et al.117

HCV: Tattoos, piercing, and acupuncture (as collectively analyzed as one outcome and reported by nextof-kin) were not associated with HCV in potential tissue donors in Sanchez et al.103

Tattoos were associated with HCV in three univariate analyses of blood donors, Orton et al.,104 ConryCantilena et al.,106 and Murphy et al. (2000)105 Orton et al. focused on having had a tattoo within the last 

six months and the appearance of acute HCV. Two of these studies also performed multivariate analyses. 

Conry-Cantilena found that tattoos were not significantly associated with infection once other factors are 

controlled for.106 Murphy et al. found that, although the odds of infection were reduced once IDU was 

controlled for, tattoos were an independent predictor of HCV.105 Three general populations studies, 

Nguyen et al.,113 Fischer et al.,114 and Hand and Vasquez et al.,112 also detected significant associations 

between tattoos and HCV. Only Hand and Vasquez investigated further and found that tattoos were an 

independent predictor. In that study, adults were enrolled based upon clinical suspicion of hepatitis. Most 

patients enrolled in the Hand and Vasquez study reported that their tattoos had been applied by friends, 

fellow gang members, or fellow inmates (as opposed to professional tattooists working from commercial 

parlors).

Among blood donors, HCV was not associated with body piercing in the last 6 months by Orton et al.,104

but was associated with ear piercing among men in Conry-Cantilena et al.,106 and with pierced ears or 

body parts in Murphy et al. (2000).105 Fischer et al.114 and Hand and Vasquez112 considered the 

association between body piercing and HCV in general population patients and did not find an 

association. Nguyen et al.113 and Hand and Vasquez112 investigated ear piercing in adult patients, and 

while Nguyen et al. detected an association Hand and Vasquez did not.
146

HIV: Tattoos, piercing, and acupuncture (as collectively analyzed as one outcome and reported by nextof-kin) were not associated with HIV in potential tissue donors in Sanchez et al.103

GRADE Summary: Tattoos and piercings were consistently not assocated with HBV. The rating of this 

evidence is low. Aside from one very low-quality study, tattoos were consistently associated with HCV, 

and piercings were inconsistently associated with HCV. The rating of this evidence is also low. Only one 

very low study considered piercing and tattoos and HIV, and did not find an association. This evidence 

was rated as very low due to low quality, lack of proof of consistency, and imprecision.

International Travel

Several studies inquired whether participants had traveled outside the U.S. but none detected an 

association with infection. Among potential tissue donors in Sanchez et al., international travel was not 

associated with HBV, HCV, or HIV.103 International travel within the last six months was not associated 

with acute HBV in a general population by Alter et al.117 Among blood donors, traveling outside the U.S.

during the last six months was not found to be significantly associated with HCV in Orton et al.,104 and 

having ever lived outside the U.S. was not found to be significantly associated with HCV in Murphy et 

al.105

GRADE Summary: International travel was not associated with any of the viruses. For HBV and HIV the 

evidence was rated as very low due to imprecision and, for HIV, low quality. For HCV the evidence was 

rated as low.
147

Evidence Tables for Question 3

Table 33. HBV Identification of Behavioral Risk Factors Data Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage ofUninfected with FactorTotal Number Uninfected

Effect Size* p-Value** 

Comparison MadeAssociated in Study?

Population

Potential Tissue Donors Sex Work

Prostitution, 

history of 

Sanchez et al.103 2006 Not 

reported

(NR)

47 NR 56 NR Not 

significant 

(NS)†

Proportion in 

HBV+ vs. 

HBVNo Potential tissue donors, 

as reported by next of kin

Incarceration

Incarceration, 

history of

Sanchez et al.103 2006 NR 47 NR 56 NR NS † Proportion in 

HBV+ vs. 

HBVNo Potential tissue donors, 

as reported by next of kin

Non-IDU Drugs

Illicit drug use 

(any)

Sanchez et al.103 2006 NR 47 NR 56 NR NS † Proportion in 

HBV+ vs. 

HBVNo Potential tissue donors, 

as reported by next of kin

Alcohol use Sanchez et al.103 2006 NR 47 NR 56 NR NS † Proportion in 

HBV+ vs. 

HBVNo Potential tissue donors, 

as reported by next of kin

Smoking 

history

Sanchez et al.103 2006 NR 47 NR 56 NR NS † Proportion in 

HBV+ vs. 

HBVNo Potential tissue donors, 

as reported by next of kin

Tattoos/Piercing

Tattoos, body 

piercing, or 

acupuncture

Sanchez et al.103 2006 NR 47 NR 56 NR NS † Proportion in 

HBV+ vs. 

HBVNo Potential tissue donors, 

as reported by next of kin
148

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage ofUninfected with FactorTotal Number Uninfected

Effect Size* p-Value** 

Comparison MadeAssociated in Study?

Population

Other

Foreign travel Sanchez et al.103 2006 NR 47 NR 56 NR NS† Proportion in 

HBV+ vs. 

HBVNo Potential tissue donors, 

as reported by next of kin

General Population MSM

Men who 

have had sex 

with men

McQuillan et 

al.29

1999 6.5% 323 1.2% 5,058 5.7

(3.4 to 9.5)†¶

<0.001† Proportion in 

HBV+ vs. 

HBVYes General population aged 17 

to 59 years

IDU

Intravenous 

drug use

Kaur et al.116 1996 62.6% 6,121 17.2% 1,417 8.11

(5.47 to 12.03)‡

SS Proportion in 

HBV+ vs. 

HBVYes Volunteers from general 

population

High-risk Sex Partner

Sex with 

intravenous 

drug user

Kaur et al.116 1996 44.7% 1,189 16.7% 5,373 2.57

(1.78 to 3.17)‡

SS Proportion in 

HBV+ vs. 

HBVYes Volunteers from general 

population

Household/ 

sexual 

contact with 

someone with 

history of IV 

drug use, 

last 6 months

Alter et al.117 1989 9% 76 0.7% 152 NR <0.01†;

NS‡

Proportion in 

HBV+ vs. 

HBVYes 

(univariate 

only)

General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Sexual 

contact with 

blood 

transfusion 

recipient

Alter et al.117 1989 3% 76 5% 152 NR NS† Proportion in 

HBV+ vs. 

HBVNo General population adults 

with no obvious cause of 

acute HBV and matched

controls
149

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage ofUninfected with FactorTotal Number Uninfected

Effect Size* p-Value** 

Comparison MadeAssociated in Study?

Population

Sexual 

contact with 

person 

employed in 

health care

Alter et al.117 1989 0% 76 5% 152 NR NS† Proportion in 

HBV+ vs. 

HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Sexual 

contact with 

person of 

foreign birth in 

area with high 

endemic HBV 

rate

Alter et al.117 1989 3% 76 0% 152 NR NS† Proportion in 

HBV+ vs. 

HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Incarceration

Imprisonment 

last 6 months

Alter et al.117 1989 7% 76 0% 152 NR <0.01†;

NS‡

Proportion in 

HBV+ vs. 

HBVYes 

(univariate 

only)

General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Other Sex Practices

Sex with 

multiple 

partners

Kaur et al.116 1996 22.6% 1,402 17.9% 5,923 1.33

(1.08 to 1.64)‡

NR Proportion in 

HBV+ vs. 

HBVYes Volunteers from general 

population

Multiple (>1) 

sexual 

partners, last 

6 months

Alter et al.117 1989 26% 76 7% 152 6.0‡ 

(confidence 

intervals not 

reported)

<0.01 Proportion in 

HBV+ vs. 

HBVYes General population adults 

with no obvious cause of 

acute HBV and matched 

controls
150

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage ofUninfected with FactorTotal Number Uninfected

Effect Size* p-Value** 

Comparison MadeAssociated in Study?

Population

Lifetime sex 

partners 

2 to 9

McQuillan et 

al.29

1999 47% 505 50% 10,613 2.1

(1.4 to 3.2)‡

SS Prevalence 

HBV+ vs. 

HBV- vs. 0 to 

1

Yes General population aged 17 

to 59 years

Lifetime sex 

partners 

10 to 49

McQuillan et 

al.29

1999 26% 505 20% 10,613 2.9

(1.9 to 4.3)‡

SS Prevalence 

HBV+ vs. 

HBV- vs. 0 to 

1

Yes General population aged 17 

to 59 years

Lifetime sex 

partners 50+

McQuillan et 

al.29

1999 4% 505 11% 10,613 6.5

(3.5 to 12.2)‡

SS Prevalence 

HBV+ vs. 

HBV- vs. 0 to

1

Yes General population aged 17 

to 59 years

Age at first 

intercourse 

<18

McQuillan et 

al.29

1999 69% 496 60% 9,978 1.2

(0.9 to 1.6)

NS Prevalence 

HBV+ vs. 

HBV- vs.

>18 years

No General population aged 17 

to 59 years

Non-Injection Drugs

Ever used 

cocaine

McQuillan et 

al.29

1999 22% 541 11% 10,773 1.8

(1.2 to 2.7)‡

SS Proportion in 

HBV+ vs. 

HBVYes General population aged 17 

to 59 years

Tattoo

Tattoo, last 

six months

Alter et al.117 1989 1% 76 1% 152 NR NS† Proportion in 

HBV+ vs. 

HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls
151

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage ofUninfected with FactorTotal Number Uninfected

Effect Size* p-Value** 

Comparison MadeAssociated in Study?

Population

Piercing

Ear piercing, 

last six 

months

Alter et al.117 1989 3% 76 3% 152 NR NS† Proportion in 

HBV+ vs. 

HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Travel

International 

travel, last 

six months

Alter et al.117 1989 1% 76 <1% 152 NR NS† Proportion in 

HBV+ vs. 

HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Other

Raw shellfish, 

ingesting, last 

six months

Alter et al.117 1989 15% 76 8% 152 NR NS† Proportion in 

HBV+ vs. 

HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Raw shellfish, 

shucking, last 

six months

Alter et al.117 1989 4% 76 3% 152 NR NS† Proportion in 

HBV+ vs. 

HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Sharing a 

razor or 

toothbrush 

with someone 

in household

Alter et al.117 1989 22% 76 27% 152 NR NS† Proportion in 

HBV+ vs. 

HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls
152

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage ofUninfected with FactorTotal Number Uninfected

Effect Size* p-Value** 

Comparison MadeAssociated in Study?

Population

Demographic and Socioeconomic Subpopulation MSM

Men who 

have sex with 

men

Hwang et al.124 2006 6% 245 3% 3,824 Relative risk 

(RR):

2.06

(1.17 to 3.61)†

OR:

3.54

(1.31 to 9.59)‡

p <0.05 

for both

Prevalence 

HBV+ vs. 

HBV- vs. 

never had 

sex

Yes College students

IDU

Intravenous 

drug use

Tabibian et al.121 2008 62.5% 40 27% 89 4.51

(2.04 to 9.96)†¶

<0.001 Prevalence in 

HBV+ vs. 

HCVYes Psychiatric inpatient 

veterans

Intravenous 

drug use

Butterfield et 

al.125

2004 NR 80 NR 276 4.54

(2.28 to 9.04)‡

<0.001 Prevalence 

HBV+ vs. 

HBVYes Psychiatric inpatient 

veterans

Intravenous 

drug use

Butterfield et 

al.126

1990 0% 12 0.2% 1,454 16.59

(0.81 to 

338.24)†¶

0.07¶ Prevalence 

HBV+ vs. 

HBVNo Obstetric population

Injected illegal 

drugs

Hwang et al.124 2006 6% 266 2% 3,968 RR:

3.02

(1.91 to 4.77)†

<0.05 Prevalence 

HBV+ vs. 

HBVYes College students

Injected 

steroids

Hwang et al.124 2006 1% 268 1% 4,013 RR:

0.98

(0.32 to 2.94)†

NS Prevalence 

HBV+ vs. 

HBVNo College students

Sex 

Work

Sex bartering Tabibian et al.121 2008 30% 40 37% 89 NR NS† Prevalence in 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans
153

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage ofUninfected with FactorTotal Number Uninfected

Effect Size* p-Value** 

Comparison MadeAssociated in Study?

Population

Unprotected 

sex for drugs

Butterfield et 

al.125

2004 NR 80 NR 276 1.25

(0.60 to 2.61)‡

NS Prevalence 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

High-Risk Sex Partners

Sex with 

intravenous 

drug user

Tabibian et al.121 2008 17.5% 40 11% 89 NR NS† Prevalence in 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Sex with 

injection drug 

user

Hwang et al.124 2006 8% 267 4% 4,006 RR:

2.05

(1.36 to 3.09)†

<0.05 Prevalence 

HBV+ vs. 

HBVYes College students

Sex with 

prostitute

Tabibian et al.121 2008 32.5% 40 18% 89 NR NS† Prevalence in 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Sexual 

partner with 

hepatitis

Hwang et al.124 2006 4% 268 2% 4,010 RR:

2.28

(1.30 to 3.99)†

p <0.05 Prevalence 

HBV+ vs. 

HBVYes College students

Sexual 

contact with 

partner with 

hepatitis

Butterfield et 

al.126

1990 0% 12 0.1% 1,454 0.36

(0.02 to 6.09)†¶

0.48¶ Prevalence 

HBV+ vs. 

HBVNo Obstetric population

Incarceration

Previous 

Incarceration

Tabibian et al.121 2008 85.0% 40 67% 89 NR <0.05† Prevalence in 

HBV+ vs. 

HBVYes Psychiatric inpatient 

veterans

Incarcerated 

>24 hours

Hwang et al.124 2006 13% 268 8% 4,026 RR:

1.71

(1.22 to 2.41)†

<0.05 Prevalence 

HBV+ vs. 

HBVYes College students
154

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage ofUninfected with FactorTotal Number Uninfected

Effect Size* p-Value** 

Comparison MadeAssociated in Study?

Population

Other Sex Practices

Lifetime 

heterosexual 

partners >0 

≤50

Hwang et al.124 2006 67% 243 74% 3,824 RR 0.89 

(0.65 to 1.24)†

NS Prevalence 

HBV+ vs. 

HBV- vs. 

no heterosexual 

partners

No College students

Lifetime 

heterosexual 

partners ≥50

Hwang et al.124 2006 4% 243 1% 3,824 RR 3.08 

(1.60 to 5.93)†

<0.05 Prevalence 

HBV+ vs. 

HBV- vs. 

no heterosexual 

partners

Yes College students

Heterosexual 

partners 

last 4 months 

≥5

Hwang et al.124 2006 3% 240 1% 3,790 RR:

2.02

(1.00 to 4.10)†;

OR:

2.61

(0.91 to 7.47)‡

NS†,

<0.05‡

Prevalence 

HBV+ vs. 

HBV- vs. <5

Yes College students

Multiple sex 

partners 

last 6 months

Butterfield et 

al.125

2004 NR 80 NR 276 2.01

(1.06 to 3.78‡

<0.05 Prevalence 

HBV+ vs. 

HBVYes Psychiatric inpatient 

veterans

Age at first 

intercourse 

≤15 years

Hwang et al.124 2006 20% 249 13% 3,810 RR:

1.52

(1.01 to 2.27)†

<0.05 Prevalence 

HBV+ vs. 

HBV- vs. 

never had 

sex

Yes College students
155

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage ofUninfected with FactorTotal Number Uninfected

Effect Size* p-Value** 

Comparison MadeAssociated in Study?

Population

Age at first 

intercourse 

≥15 years

Hwang et al.124 2006 65% 249 70% 3,810 RR:

0.97

(0.69 to 1.36)†

NS Prevalence 

HBV+ vs. 

HBV- vs. 

never had 

sex

No College students

Non-Injection Substance 

Intranasal 

drug use

Tabibian et al.121 2008 80% 40 66% 89 NR NS† Prevalence in 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Intranasal 

drug use

Hwang et al.124 2006 19% 262 14% 3,921 RR:

1.39

(1.03 to 1.86)†

<0.05 Prevalence 

HBV+ vs. 

HBVYes College students

Sniffed/

snorted drugs

Butterfield et 

al.125

2004 NR 80 NR 276 1.06

(0.51 to 2.21)‡

NS Prevalence 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Smoked crack 

cocaine

Butterfield et 

al.125

2004 NR 80 NR 276 1.18

(0.55 to 2.54)‡

NS Prevalence 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Alcohol use 

disorder

Butterfield et 

al.125

2004 NR 80 NR 276 0.93

(0.52 to 1.69)‡

NS Prevalence 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Tattoo

Tattoo Tabibian et al.121 2008 40% 40 30% 89 NR NS† Prevalence 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Tattoo Hwang et al.124 2006 25% 274 26% 4,047 RR:

0.96

(0.73 to 1.25)†

NS Prevalence 

HBV+ vs. 

HBVNo College students
156

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage ofUninfected with FactorTotal Number Uninfected

Effect Size* p-Value** 

Comparison MadeAssociated in Study?

Population

Tattoo Butterfield et 

al.126

1990 0 12 4.6% 1,454 0.82

(0.05 to 

14.06)†¶

0.893¶ Prevalence 

HBV+ vs. 

HBVNo Obstetric population

Tattoo, 

number of, 

1-2

Hwang et al.124 2006 20% 274 20% 4,039 RR:

0.99

(0.74 to 1.32)†

NS Prevalence 

HBV+ vs. 

HBV- vs. 

no tattoo

No College students

Tattoo, 

number of ≥3

Hwang et al.124 2006 5% 274 5% 4,039 RR:

0.87

(0.50 to 1.50)†

NS Prevalence 

HBV+ vs. 

HBV- vs. 

no tattoo

No College students

Tattooed in 

professional 

setting

Hwang et al.124 2006 21% 274 22% 4,035 RR:

0.93

(0.70 to 1.23)†

NS Prevalence 

HBV+ vs. 

HBV- vs. 

no tattoo

No College students

Tattooed in 

nonprofessional 

setting

Hwang et al.124 2006 4% 274 3% 4,035 RR:

1.24

(0.69 to 2.23)†

NS Prevalence 

HBV+ vs. 

HBV- vs. 

no tattoo

No College students

Tattooed with 

new or 

autoclaved 

needles only

Hwang et al.124 2006 18% 267 21% 3,920 RR:

0.87

(0.65 to 1.18)†

NS Prevalence 

HBV+ vs. 

HBV- vs. 

no tattoo

No College students

Tattooed with 

reused nonautoclaved 

needles

Hwang et al.124 2006 4% 267 2% 3,920 RR:

1.91

(1.11 to 3.30)†

<0.05 Prevalence 

HBV+ vs. 

HBV- vs. 

no tattoo

Yes College students
157

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage ofUninfected with FactorTotal Number Uninfected

Effect Size* p-Value** 

Comparison MadeAssociated in Study?

Population

Tattooed with 

ink in single 

wells only

Hwang et al.124 2006 12% 242 15% 3,646 RR:

0.79

(0.55 to 1.15)†

NS Prevalence 

HBV+ vs. 

HBV- vs. 

no tattoo

No College students

Tattooed with 

ink in 

common wells

Hwang et al.124 2006 2% 242 2% 3,646 RR:

1.10

(0.50 to 2.41)†

NS Prevalence 

HBV+ vs. 

HBV- vs. 

no tattoo

No College students

Piercing

Piercing Tabibian et al.121 2008 37.5% 40 30% 89 NR NS† Prevalence in 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Body piercing 

(other than 

ears)

Hwang et al.124 2006 16% 268 21% 4,008 RR:

0.74

(0.54 to 1.02)†

NS Prevalence 

HBV+ vs. 

HBVNo College students

Number of 

body 

piercings 1-2

Hwang et al.124 2006 14% 266 17% 3,975 RR:

0.77

(0.55 to 1.08)†

NS Prevalence 

HBV+ vs. 

HBV- vs. 

no piercing

No College students

Number of 

body 

piercings ≥3

Hwang et al.124 2006 2% 266 3% 3,975 RR:

0.55

(0.23 to 1.30)†

NS Prevalence 

HBV+ vs. 

HBV- vs. 

no piercing

No College students
158

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage ofUninfected with FactorTotal Number Uninfected

Effect Size* p-Value** 

Comparison MadeAssociated in Study?

Population

Other

Professional 

manicure

Hwang et al.124 2006 56% 272 54% 4,033 RR:

1.08

(0.86 to 1.37)†

NS Prevalence 

HBV+ vs. 

HBV- vs. 

no manicure

No College students

Do not always 

wear gloves 

while 

embalming

Turner et al.127 1989 NR 14 NR 94 RR:

9.8

(3.4 to 28.5)†

NR Prevalence 

HBV+ vs. 

HBV- vs. 

wears gloves

Yes Embalmers in highprevalence urban area

Do not always 

wear gowns, 

aprons, shoe 

coverings, 

goggles, 

glasses, or 

face masks

Turner et al.127 1989 NR 14 NR 94 NR NR Prevalence 

HBV+ vs. 

HBV- vs. 

does wear

No Embalmers in highprevalence urban area

Eat or drink 

while 

embalming

Turner et al.127 1989 NR 14 NR 94 RR:

1.8

(0.66 to 4.7)† 

NR Prevalence 

HBV+ vs. 

HBV- vs. 

does not

No Embalmers in highprevalence urban area

Smoke while 

embalming

Turner et al.127 1989 NR 14 NR 94 RR:

1.6

(0.58 to 4.3)† 

NR Prevalence 

HBV+ vs. 

HBV- vs. 

does not

No Embalmers in highprevalence urban area

* Odds ratios as reported in publication, unless otherwise specified

** As reported in publication, unless otherwise specified

† Univariate, unadjusted

‡ Multivariate, adjusted for other factors

¶ Calculated by ECRI Institute

NR – Not reported
159

Table 34. HCV Identification of Behavioral Risk Factors Data Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Potential Organ Donors Non-injection Drugs

Alcohol -

‘Heavy’ use

Gasink et 

al.102

2006 49.2% 261 19.9% 10,654 Not reported 

(NR)

<0.001† Proportion in 

HCV+ vs. 

HCVYes Heart donors

Tobacco use, 

history of

Gasink et 

al.102

2006 69.0% 261 35.4% 10,654 NR <0.001† Proportion in 

HCV+ vs. 

HCVYes Heart donors

Potential Tissue Donors Sex Work

Prostitution, 

history of

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS Proportion in 

HCV+ vs. 

HCVNo Potential tissue 

donors, as reported 

by next of kin

Incarceration

Incarceration, 

history of

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS Proportion in 

HCV+ vs. 

HCVNo Potential tissue 

donors, as reported 

by next of kin
160

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Non-injection Drugs

Illicit drug use Sanchez et 

al.103

2006 NR 18 NR 56 4.65

(1.21 to 17.91)

X2 = 0.016 Proportion in 

HCV+ vs. 

HCVYes Potential tissue 

donors, as reported 

by next of kin

Alcohol use Sanchez et 

al.103

2006 NR 18 NR 56 NR NS Proportion in 

HCV+ vs. 

HCVNo Potential tissue 

donors, as reported 

by next of kin

Cigarette 

smoking

Sanchez et 

al.103

2006 NR 18 NR 56 4.01

(1.11 to 14.65) 

X2 = 0.024 Proportion in 

HCV+ vs. 

HCVYes Potential tissue 

donors, as reported 

by next of kin

Tattoos and Piercing

Tattoos, body 

piercing, or 

acupuncture

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS Proportion in 

HCV+ vs. 

HCVNo Potential tissue 

donors, as reported 

by next of kin

Travel

Foreign travel Sanchez et 

al.103

2006 NR 18 NR 56 NR NS Proportion in 

HCV+ vs. 

HCVNo Potential tissue 

donors, as reported 

by next of kin
161

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Blood Donors MSM

Men: Number 

of lifetime 

male partners 

1

Murphy et 

al.105

2000 3% 400 1% 568 0.9

(0.2 to 4.4)‡

NS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU with 

reference to 

0 partners

No Blood donors

Men: Number 

of lifetime 

male partners 

2+

Murphy et 

al.105

2000 6% 400 1% 568 1.1

(0.2 to 5.4)‡

NS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU with 

reference to 

0 partners

No Blood donors

Men: 

Bisexual/ 

homosexual

Murphy et 

al.105

2000 8% 758 2% 1,039 1.0

(0.3 to 3.0)‡

NS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU with 

reference to 

hetero-sexual

No Blood donors
162

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

IDU

Injection drug 

use in 

last 6 months

Orton et al.104 2004 29.2% 65 0% 225 61.46

(7.81 to 

483.67)†¶

(Reported as 

undefined in 

original 

publication due 

to absence of 

factor in 

uninfected 

group)

<0.001† Proportion in 

HCV+ vs. 

HCVYes Blood donors

Intravenous 

drug use

ConryCantilena et 

al.106

1996 42% 248 2% 131 12.5

(2.7 to 57.1)‡

0.001 Proportion in 

HCV+ vs. 

HCVYes Blood donors initially 

positive on enzyme 

linked 

immunosorbent 

assay (EIA)

Injected drugs Murphy et 

al.105

2000 51% 758 1% 1,039 49.6

(20.3 to 

121.1)‡

Statistically 

significant 

(SS)

Proportion in 

HCV+ vs. 

HCV- final

multivariable 

logistic 

regression 

model

Yes Blood donors

Injection drug 

use longer 

than 6 months 

ago only

Orton et al.104 2004 4.9% 46 0.5%% 225 10.9

(0.6 to 647)†

0.07 Proportion in 

HCV+ vs. 

HCVNo Blood donors
163

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Injection 

steroid use 

longer than 

6 months ago 

only

Orton et al.104 2004 3.5% 65 0.5% 225 7.6

(0.4 to 448)†

0.12 HCV- No Blood donors

Lived with 

injection drug 

user

Murphy et 

al.105

2000 38% 758 1% 1,039 5.1

(2.9 to 8.8)‡

SS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU

Yes Blood donors

Reside with 

an injection 

drug user in 

last 6 months

Orton et al.104 2004 7.7% 65 0% 225 Undefined 

(because zero 

controls 

reported this 

factor)

<0.001† Proportion in 

HCV+ vs. 

HCVYes Blood donors

Sex Work

Received 

money for sex

Murphy et 

al.105

2000 7% 758 1% 1,039 3.0

(0.9 to 9.7)‡

SS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU

Yes Blood donors

High-risk 

Sex 

PartnersSex with 

injection drug 

user in 

last 6 months

Orton et al.104 2004 18.5% 65 1.8% 225 12.5

(3.6 to 54)†

<0.001 Proportion in 

HCV+ vs. 

HCVYes Blood donors
164

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Sex with 

injection drug 

user in last 

6 months

Murphy et 

al.105

2000 41% 758 3% 1,039 6.3

(3.3 to 12.0)‡

SS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU

Yes Blood donors

Gave money 

for sex

Murphy et 

al.105

2000 15% 758 6% 1,039 1.5

(0.9 to 2.5)‡

SS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU

Yes Blood donors

Sex with 

hepatitis case

Murphy et 

al.105

2000 7% 758 3% 1,039 2.2

(1.1 to 4.5)‡

SS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU

Yes Blood donors

Sex partner 

had hepatitis 

in last 

6 months

Orton et al.104 2004 7.7% 65 1.8% 225 4.6

(1.0 to 24)†

0.03 Proportion in 

HCV+ vs. 

HCVYes Blood donors

Sex with 

transfusion 

recipient

Murphy et 

al.105

2000 5% 758 3% 1,039 2.5

(1.3 to 5.0)‡

SS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU

Yes Blood donors
165

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Incarceration

Been in jail 

within 

6 months of 

donation

Orton et al.104 2004 30.9% 65 12.0% 225 3.3

(1.6 to 6.6)†

<0.001 Proportion in 

HCV+ vs. 

HCVYes Blood donors

Been in jail 

at least 

6 months 

before 

donation

Orton et al.104 2004 30.9% 65 12.0% 225 3.3

(1.6 to 6.6)†

<0.001 Proportion in 

HCV+ vs. 

HCVYes Blood donors

In jail more 

than 3 days

Murphy et 

al.105

2000 22% 758 2% 1,039 5.0

(2.6 to 9.8)‡

SS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU

Yes Blood donors

Imprisonment 

(history of)

ConryCantilena et 

al.106

1996 25% 248 2% 131 NR <0.001†;

NS‡

Proportion in 

HCV+ vs. 

HCVYes; Univariate 

only

Blood donors initially 

positive on EIA

Other Sex Practices

Sexual 

promiscuity 

(history of 

STD, sex with 

prostitute, 

>5 partners/ 

year)

ConryCantilena et 

al.106

1996 53% 248 24% 131 3.0

(1.5 to 5.9)‡

0.002 Proportion in 

HCV+ vs. 

HCVYes Blood donors initially 

positive on EIA
166

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Men:

Number of 

lifetime 

female 

partners 1

Murphy et 

al.105

2000 8% 400 24%% 568 0.8

(0.3 to 2.6)‡

NS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU with 

reference to 0

No Blood donors

Men:

Number of 

lifetime 

female 

partners 2-10

Murphy et 

al.105

2000 38% 400 44% 568 1.5

(0.6 to 4.0)‡

NS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU with 

reference to 

0 partners

No Blood donors

Men:

Number of 

lifetime 

female 

partners 11+

Murphy et 

al.105

2000 51% 400 24% 568 1.7

(0.6 to 4.8)‡

NS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU with 

reference to 

0 partners

No Blood donors

Men:

Not sexually 

active

Murphy et 

al.105

2000 3% 400 6% 568 0.7

(0.2 to 2.0)‡

NS Proportion in 

HCV+ vs. 

HCV- with 

reference to 

hetero-sexual

No Blood donors
167

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Women:

Number of 

lifetime male 

partners 1

Murphy et 

al.105

2000 13% 351 32% 463 1.2

(0.5 to 3.3)‡

NS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU with 

reference to

0 partners

No Blood donors

Women:

Number of 

lifetime male 

partners 2-10

Murphy et 

al.105

2000 46% 351 50% 463 1.9

(0.7 to 5.0)‡

NS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU with 

reference to 

0 partners

No Blood donors

Women:

Number of 

lifetime male 

partners 

11-49

Murphy et 

al.105

2000 28% 351 11% 463 3.2

(1.1 to 9.1)‡

SS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU with 

reference to 

0 partners

Yes Blood donors

Women:

Number of 

lifetime male 

partners 50+

Murphy et 

al.105

2000 8% 351 1% 463 8.8

(2.0 to 39.4)‡

SS Proportion in 

HCV+ vs. 

HCV- with 

reference to 

0 partners

Yes Blood donors
168

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Women: 

Not sexually 

active

Murphy et 

al.105

2000 3% 351 4% 463 0.9

(0.3 to 2.4)‡

NS Proportion 

with HCV+ vs. 

HCV- adjusted 

for IDU and 

compared to 

hetero-sexual

No Blood donors

Two or more 

sexual 

partners in 

last 6 months

Orton et al.104 2004 21.5% 65 4.9% 225 5.3

(2.3 to 13)†

<0.001 Proportion in 

HCV+ vs. 

HCVYes Blood donors

Women: 

Number of 

lifetime 

female 

partners >1

Murphy et 

al.105

2000 6% 351 2% 463 1.3

(0.4 to 4.4)‡

NS‡ (Unadjusted 

was SS)

Proportion 

with HCV+ vs. 

HCV- adjusted 

for IDU and 

compared to 

0 lifetime 

female 

partners

No 

(Once 

adjusted 

for IDU)

Blood donors

Women: 

Number of 

lifetime 

female 

partners >2

Murphy et 

al.105

2000 9% 351 2% 463 3.7

(1.2 to 11.1)‡

SS Proportion 

with HCV+ vs. 

HCV- adjusted 

for IDU and 

compared to 

0 lifetime 

female 

partners

Yes Blood donors
169

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Women: 

Sexual 

orientation 

bisexual/ 

homosexual

Murphy et 

al.105

2000 16% 351 4% 463 2.3

(1.0 to 5.2)‡

NS Proportion 

with HCV+ vs. 

HCV- adjusted 

for IDU and 

compared to 

heterosexual

No 

(when 

adjusted 

for IDU)

Blood donors

Non-injection Drugs

Snort drugs in 

last 6 months

Orton et al.104 2004 20.0% 65 0% 225 Undefined 

(because 

zero controls 

reported this 

factor)

<0.001† Proportion in 

HCV+ vs. 

HCVYes Blood donors

Intranasal 

drugs longer 

than 6 months 

ago

Orton et al.104 2004 17.4% 52 6.6% 225 3.0

(1.0 to 8.2)†

0.04† Proportion in 

HCV+ vs. 

HCVYes Blood donors

Intranasal 

cocaine use

ConryCantilena et 

al.106

1996 68% 248 11% 131 8.0

(3.9 to 16.5)‡

<0.001 Proportion in 

HCV+ vs. 

HCVYes Blood donors initially 

positive on EIA

Inhaled drugs Murphy et 

al.105

2000 63% 758 21% 1,039 2.2

(1.6 to 3.1)‡

SS Proportion in 

HCV+ vs. 

HCVAdjusted for 

IDU

Yes Blood donors

Friends use 

street drugs in 

last 6 months

Orton et al.104 2004 38.5% 65 6.7% 225 8.8

(4.2 to 18)†

<0.001 Proportion in 

HCV+ vs. 

HCVYes Blood donors
170

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Tattoo

Tattoo in

last 6 months

Orton et al.104 2004 4.6% 65 0.5% 225 11

(0.8 to 566)†

0.04 Proportion in 

HCV+ vs. 

HCVYes Blood donors

Tattoo ConryCantilena et 

al.106

1996 21% 248 4% 131 NR p <0.001†;

NS‡

Proportion in 

HCV+ vs. 

HCVYes; univariate 

only

Blood donors initially 

positive on EIA

Tattoo Murphy et 

al.105

2000 27% 758 5% 1,039 3.9

(2.5 to 6.1)‡

SS Proportion in 

HCV+ vs. 

HCV- adjusted 

for IDU

Yes Blood donors

Piercing

Had body 

piercing in 

last 6 months

Orton et al.104 2004 4.6% 65 2.2% 225 2.1

(0.3 to 11)†

0.38 Proportion in 

HCV+ vs. 

HCVNo Blood donors

Ear piercing 

among men

ConryCantilena et 

al.106

1996 30% 139 0% 83 NR <0.05‡ Proportion in 

HCV+ vs. 

HCVYes Blood donors initially 

positive on EIA 

(male only; factor 

not significant 

among women)

Pierced ears/ 

body parts

Murphy et 

al.105

2000 56% 758 40% 1,039 2.0

(1.1 to 3.7)‡

SS Proportion in 

HCV+ vs. 

HCV- final 

multivariable 

logistic 

regression 

model

Yes Blood donors
171

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Travel

Travel outside 

U.S. in 

last 6 months

Orton et al.104 2004 1.5% 65 6.7% 225 0.2

(0.01 to 1.5)†

0.13 Proportion in 

HCV+ vs. 

HCVNo Blood donors

Lived outside 

the U.S.

Murphy et 

al.105

2000 17% 758 15% 1,039 1.0

(0.7 to 1.5)‡

NS Proportion in 

HCV+ vs. 

HCV- adjusted 

for IDU

No Blood donors

Other

Religious 

scarification

Murphy et 

al.105

2000 8% 758 2% 1,039 2.8

(1.2 to 7.0)‡

SS Proportion in 

HCV+ vs. 

HCV- final 

multivariable 

logistic 

regression 

model

Yes Blood donors

Shared 

toothbrush/ 

razor

Murphy et 

al.105

2000 16% 758 7% 1,039 1.6

(1.0 to 2.5)‡

SS Proportion in 

HCV+ vs. 

HCV- adjusted 

for IDU

Yes Blood donors
172

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Electrolysis 

hair removal

Murphy et 

al.105

2000 3% 758 3% 1,039 1.2

(0.6 to 2.6)‡

NS Proportion in 

HCV+ vs. 

HCV- adjusted 

for IDU

No Blood donors

General Population MSM

Men who 

have sex with 

men

Hand and 

Vasquez112

2005 5% 320 6% 307 NR 0.658† Proportion 

HCV+ vs. 

HCVNo Adults tested for 

HCV in health 

system because of 

clinical suspicion

IDU

Drug use –

Injection, 

lifetime 

Armstrong et 

al.30

2006 45% 114 0.7% 5,254 148.9

(44.9 to 49.4)‡

SS No use (or 

marijuana 

only) HCV+

Yes General population 

aged 20 to 59 years

Injected drugs Fischer et 

al.114

2000 27% 11 2% 1,369 26.47

(8.39 to 

83.55)‡¶

<0.001† Proportion in 

HCV+ vs. 

HCVYes Adults enrolled in 

HMO

Injection drug 

use

Hand and 

Vasquez112

2005 53% 320 5% 307 20.1

(10.3 to 39.4)‡

<0.0001 Proportion in 

HCV+ vs. 

HCVYes Adults tested for 

HCV in health 

system because of 

clinical suspicion

Intravenous 

drug use

Kaur et al.116 1996 66.6% 6,121 5.2% 528 23.34

(15.21 to 

35.81)‡

SS Proportion in 

HCV+ vs. 

HCVYes Volunteers from 

general population
173

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size*p-Value**

Comparison MadeAssociated in Study?

Population

Being at a 

social 

gathering with 

injecting 

drugs

Nguyen et 

al.113

2005 45.0% 225 7.4% 204 NR <0.001 Proportion 

HCV+ vs. 

HCV-

Yes Adults at general 

internal medicine 

clinic (controls) and hepatology clinic 

(cases)

Seeing use of 

injecting 

drugs

Nguyen et 

al.113

2005 55.0% 225 10.8% 204 NR <0.001 Proportion 

HCV+ vs. 

HCV-

Yes Adults at general 

internal medicine 

clinic (controls) and 

hepatology clinic 

(cases)

Sex Work

Female 

prostitutes

Hand and 

Vasquez112

20052% 3200% 307 NR 0.028† Proportion 

HCV+ vs. 

HCV-

Yes Adults tested for 

HCV in health 

system because of 

clinical suspicion

Exchanging 

sex for money

Nguyen et 

al.113

2005 17.1% 225 2.0% 204 NR <0.001† Proportion 

HCV+ vs. 

HCV-

Yes Adults at general 

internal medicine 

clinic (controls) and 

hepatology clinic 

(cases)

High-risk Sex Partners

Sex with 

injecting drug 

users

Nguyen et 

al.113

2005 37.8% 225 3.4% 204 5.39

(2.01 to 

14.42)† 

<0.001 Proportion 

HCV+ vs. 

HCV-

Yes Adults at general 

internal medicine 

clinic (controls) and 

hepatology clinic 

(cases)

Sex with 

intravenous 

drug users

Kaur et al.116 1996 45.7% 408 4.7%

5,373 7.29

(4.74 to 

11.21)‡

NR Proportion in 

HCV+ vs. 

HCV-

Yes Volunteers from 

general population
174

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size*p-Value**

Comparison MadeAssociated in Study?

Population

Sex with 

prostitute

Nguyen et 

al.113

2005 20.7% 225 1.5% 204 9.76

(2.50 to 

38.13)† 

<0.01† Proportion 

HCV+ vs. 

HCV-

Yes Adults at general 

internal medicine 

clinic (controls) and 

hepatology clinic 

(cases)

Sex with 

prostitutes

Hand and 

Vasquez112

20053% 320 0.7% 307 NR†; 

3.4

(0.6 to 18.9)‡

0.014†;

0.169‡

Proportion in 

HCV+ vs. 

HCV-

Yes; uni-

variate 

only

Adults tested for 

HCV in health 

system because of 

clinical suspicion

Incarceration

Arrested, 

having been

Nguyen et 

al.113

2005 33.3% 225 6.9% 204 NR <0.001† Prevalence in 

HCV+ vs. 

HCV-

Yes Adults at general 

internal medicine 

clinic (controls) and 

hepatology clinic 

(cases)

Additional Sex Practices

Unprotected 

sex

Fischer et 

al.114

2000 45% 11 12%1,369 NR <0.001† Proportion in 

HCV+ vs. 

HCV-

Yes Adults enrolled in 

HMO

Number of 

sex partners –

0

Nguyen et 

al.113

2005 11.7% 225 8.8% 204 NR <0.01† Proportion with 

factor HCV+ 

vs. HCV-

Yes Adults at general 

internal medicine 

clinic (controls) and 

hepatology clinic 

(cases) Number of

sex partners –

1

Nguyen et 

al.113

2005 7.2% 225 17.2% 204

Number of 

sex partners –

2-9

Nguyen et 

al.113

2005 32.4% 225 46.6% 204
175

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Number of 

sex partners –

10-49

Nguyen et 

al.113

2005 37.8% 225 25.0% 204

Number of 

sex partners –

At least 50

Nguyen et 

al.113

2005 10.8% 225 2.5% 204

Number of 

sex partners 

2-19

Armstrong et 

al.30

2006 27% 179 63% 5,178 1.4

(0.3 to 6.0)‡

NR 0-1 partners 

prevalence of

HCV+

No General population 

aged 20 to 59 years

Number of 

sex partners 

≥20

Armstrong et 

al.30

2006 39% 179 14% 5,178 5.2

(1.5 to 18.2)‡

NR 0-1 partners 

prevalence of 

HCV+

Yes General population 

aged 20 to 59 years

Frequent sex 

partners

Fischer et 

al.114

2000 36% 11 7% 1,369 NR <0.001† Proportion in 

HCV+ vs. 

HCVYes Adults enrolled in 

HMO

Sex with 

multiple 

partners

Kaur et al.116 1996 13.5% 542 6.5% 5,923 2.24

(1.87 to 2.69)†

NR Proportion in 

HCV+ vs. 

HCVYes Volunteers from 

general population

Sex with 

person of 

same sex 

(not restricted 

to MSM)

Nguyen et 

al.113

2005 8.6% 225 8.8% 204 NR >0.99† Proportion 

HCV+ vs. 

HCVNo Adults at general 

internal medicine 

clinic (controls) and 

hepatology clinic 

(cases)
176

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Age at 

first sexual 

intercourse 

16-17 years 

(participants 

aged 20 to 

59 years)

Armstrong et 

al.30

2006 27% 126 30% 4,928 NR <0.05† HCV+ with 

first sexual 

intercourse 

≥18 years

Yes General population 

aged 20 to 59 years

Age at 

first sexual 

intercourse 

12-15 years 

(participants 

aged 20 to 

59 years)

Armstrong et 

al.30

2006 47% 126 26% 4,928 NR <0.005† HCV+ with 

first sexual 

intercourse 

≥18 years

Yes General population 

aged 20 to 59 years

Age at 

first sexual 

intercourse 

≤11 years 

(participants 

aged 20 to 

59 years)

Armstrong et 

al.30

2006 11% 126 2.5% 4,928 NR <0.05† HCV+ with 

first sexual 

intercourse 

≥18 years

Yes General population 

aged 20 to 59 years

Non-injection 

Drugs

Drug use –

noninjection 

(except 

marijuana)

Armstrong et 

al.30

2006 29% 114 2.2% 5,254 3.7

(1.7 to 7.9)‡

NR No drug use or 

only marijuana, 

HCV+

Yes General population 

aged 20 to 59 years
177

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Snorting or 

inhaling nonprescription 

drugs

Nguyen et 

al.113

2005 55.4% 225 18.1% 204 NR <0.00† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) and 

hepatology clinic 

(cases)

Inhaled 

cocaine

Fischer et 

al.114

2000 18% 11 2% 1,369 NR <0.05† Proportion in 

HCV+ vs. 

HCVYes Adults enrolled in 

HMO

Intranasal 

cocaine

Hand and 

Vasquez112

2005 39% 320 14% 307 NR†, 

1.4

(0.8 to 2.4)‡

<0.0001†; 

0.283‡

Proportion in 

HCV+ vs. 

HCVYes; univariate 

only

Adults tested for 

HCV in health 

system because of 

clinical suspicion

Being at a 

social 

gathering with 

cocaine

Nguyen et 

al.113

2005 66.2% 225 28.4% 204 NR <0.001† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) and 

hepatology clinic 

(cases)

Alcohol use –

none/missing 

weekly

Nguyen et 

al.113

2005 15.3% 225 11.8% 204 NR 0.12† Prevalence of 

factor in HCV+ 

vs. HCVNo Adults at general 

internal medicine 

clinic (controls) and 

hepatology clinic 

(cases) Alcohol use –

<1 drink 

weekly

Nguyen et 

al.113

2005 59.0% 225 52.5% 204

Alcohol use –

1-5 drinks 

weekly

Nguyen et 

al.113

2005 15.3% 225 27.9% 204
178

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Alcohol use –

More than 

5 drinks 

weekly

Nguyen et 

al.113

2005 10.4% 225 7.8% 204

Alcoholism Fischer et 

al.114

2000 18% 11 9% 1,369 NR NS † Proportion in 

HCV+ vs. 

HCVNo Adults enrolled in 

HMO

Moderate to 

heavy alcohol 

use (at least 

2 units per 

day)

Hand and 

Vasquez112

2005 58% 320 49% 307 NR 0.034† Proportion in 

HCV+ vs. 

HCVYes Adults tested for 

HCV in health 

system because of 

clinical suspicion

Tattoo

Tattoo Nguyen et 

al.113

2005 28.4% 225 16.2% 204 NR 0.003† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) and 

hepatology clinic 

(cases)

Tattoo Fischer et 

al.114

2000 36% 11 6% 1,369 NR <0.001† Proportion in 

HCV+ vs. 

HCVYes Adults enrolled in 

HMO

Tattoo Hand and 

Vasquez112

2005 57% 320 22% 307 NR†;

2.9

(1.9 to 4.6)‡

<0.0001†;

<0.001‡

Proportion in 

HCV+ vs. 

HCVYes Adults tested for 

HCV in health 

system because of 

clinical suspicion
179

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison

Made

Associated in Study?

Population

Piercing

Pierced ears Nguyen et 

al.113

2005 59.0% 225 73.5% 204 NR 0.002† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) and 

hepatology clinic 

(cases)

Pierced ears Hand and 

Vasquez112

2005 38% 320 38% 307 NR 0.998† Proportion 

HCV+ vs. 

HCVNo Adults tested for 

HCV in health 

system because of 

clinical suspicion

Body piercing Fischer et 

al.114

2000 45% 11 33% 1,369 NR NS† Proportion 

HCV+ vs. 

HCVNo Adults enrolled in 

HMO

Body piercing Hand and 

Vasquez112

2005 2% 320 3% 307 NR 0.737† Proportion in 

HCV+ vs. 

HCVNo Adults tested for 

HCV in health 

system because of 

clinical suspicion

Other

No lifestyle 

risks

Fischer et 

al.114

2000 0% 11 32% 1,369 NR <0.05† Proportion in 

HCV+ vs. 

HCVYes Adults enrolled in 

HMO

* Odds ratios as reported in publication, unless otherwise specified

** As reported in publication, unless otherwise specified

† Univariate, unadjusted

‡ Multivariate, adjusted for other factors

¶ Calculated by ECRI Institute
180

Table 35. HIV Identification of Behavioral Risk Factors Data

Category Factor Citation Year

Percentage of Infectedwith FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated 

in Study? Population

Potential Tissue Donors Sex Work

Prostitution, 

history of

Sanchez et 

al.103

2006 Not 

reported 

(NR)

10 NR 56 NR Not 

significant 

(NS) 

Proportion in 

HIV+ vs. HIV

No Potential tissue 

donors, as reported 

by next of kin

Incarceration

Incarceration, 

history of

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIV

No Potential tissue 

donors, as reported 

by next of kin

Non-IDU

Illicit drug use Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. 

HIVNo Potential tissue

donors, as reported 

by next of kin

Smoking 

history

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIV

No Potential tissue 

donors, as reported 

by next of kin

Alcohol use Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIV

No Potential tissue 

donors, as reported 

by next of kin

Tattoos and Piercing

Tattoos, body 

piercing, or 

acupuncture

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIV

No Potential tissue 

donors, as reported 

by next of kin

Travel

Foreign travel Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIV

No Potential tissue 

donors, as reported 

by next of kin
181

Category Factor Citation Year

Percentage of Infectedwith FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated 

in Study? Population

General Population MSM

Male-to-male 

sex

McQuillan et 

al.101

2006 52% 21 4% 2,418 26.0

(10.8 to 62.7)†¶

<0.001 Proportion in 

HIV+ vs. 

HIVYes General population

MSM, ever, 

men only

Nguyen et 

al.110

2008 53.8% 13 8.3% 577 15.11

(4.11 to 55.91)†

SS Men who 

have had 

sex with 

women HIV+ 

vs. HIVYes General population of 

adults in New York 

City who have ever 

had sex

IDU

Injection drug 

use

Mehta et 

al.109

2008 9% 229 NR 16,467 1.17

(0.75 to 1.85)†

NR Percent 

HIV+ vs. no 

injection 

drug use

No Hospital inpatients 

and outpatients

Ever injected 

drugs

McQuillan et 

al.101

2006 13% 30 2% 4,938 7.3

(2.5 to 21.6)†¶

0.001 Proportion in 

HIV+ vs. 

HIVYes General population

Ever used a 

needle for 

drugs

Nguyen et 

al.110

2008 14.3% 21 1.2% 1,482 21.01

(3.99 to 110.64)†

SS Never used 

needle

Yes General population of 

adults in New York 

City

High-risk Sex 

Partners

Sex with HIV+ 

person

Mehta et 

al.109

2008 10% 229 NR 16,467 3.25

(2.11 to 5.01)†

NR No sex with 

HIV+ person 

in HIV+

Yes Hospital inpatients 

and outpatients
182

Category Factor Citation Year

Percentage of Infectedwith FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated 

in Study? Population

Other Sex Practices

Number of sex 

partners 1

Mehta et 

al.109

2008 22% 229 NR 16,467 0.79

(0.41 to 1.53)†

NR 0 partners, 

HIV+

No Hospital inpatients 

and outpatients

Number of sex 

partners 2-4

Mehta et 

al.109

2008 34% 229 NR 16,467 1.03

(0.55 to 1.95)†

NR 0 partners, 

HIV+

No Hospital inpatients 

and outpatients

Number of sex 

partners 5-9

Mehta et 

al.109

2008 12% 229 NR 16,467 1.09

(0.54 to 2.20)†

NR 0 partners, 

HIV+

No Hospital inpatients 

and outpatients

Number of sex 

partners ≥10

Mehta et 

al.109

2008 10% 229 NR 16,467 1.14

(0.55 to 2.36)†

NR 0 partners, 

HIV+

No Hospital inpatients 

and outpatients

Number of sex 

partners –

Data Missing

Mehta et 

al.109

2008 17% 229 NR 16,467 0.92

(0.47 to 1.80)†

NR 0 partners, 

HIV+

No Hospital inpatients 

and outpatients

Lifetime sex 

partners 0-1

McQuillan et 

al.

101

2006 13% 31 26% 5,360 0.43

(0.15 to 1.2)†¶

0.11 Proportion 

HIV+ vs. 

HIVNo General population

Lifetime sex 

partners 2-49

McQuillan et 

al.101

2006 55% 31 71% 5,360 0.50

(0.25 to 1.02)†¶

0.55 Proportion 

HIV+ vs. HIV

No General population

Lifetime sex 

partners 50+

McQuillan et 

al.101

2006 32% 31 4% 5,360 11.3

(5.5 to 24.3)†¶

<0.001 Proportion 

HIV+ vs. HIV

Yes General population

Multiple sex 

partners in 

past year

Nguyen et 

al.110

2008 30.0% 20 22.1% 1,346 1.41

(0.59 to 3.37)†

NS Single sex 

partner past 

year

No General population of 

adults in New York 

City who have ever 

had sex
183

Category Factor Citation Year

Percentage of Infectedwith FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated 

in Study? Population

Sex partner 

same gender 

or both

Mehta et 

al.109

2008 16% 229 NR 16,467 2.17

(1.49 to 3.15)†

NR Prevalence 

of HIV+ with 

this factor 

vs. opposite 

gender only

Yes Hospital inpatients 

and outpatients

Age at first 

intercourse 

<18 years

McQuillan et 

al.101

2006 77% 31 58% 5,342 2.4

(1.0 to 5.6)†¶

0.038 Proportion in 

HIV+ vs. 

HIVYes General population

Condom use, 

past month

Nguyen et 

al.110

2008 33.3 3 59.2 238 0.32

(0.03 to 3.83)†

NS Sometimes 

or never 

used 

condoms

No General population of 

adults in New York 

City who reported 

multiple sex partners 

during the past year 

and sexual activity 

during the past month

Condom use 

with current 

partner –

Sometimes

Mehta et 

al.109

2008 52% 229 NR 16,467 1.14

(0.76 to 1.70)†

NR Prevalence 

of condom 

use always, 

HIV+

No Hospital inpatients 

and outpatients

Condom use 

with current 

partner –

Never

Mehta et 

al.109

2008 20% 229 NR 16,467 0.75

(0.47 to 1.19)†

NR Prevalence 

of condom

use always, 

HIV+

No Hospital inpatients 

and outpatients

Condom use 

with current 

partner –

Missing Data

Mehta et 

al.109

2008 14% 229 NR 16,467 1.54

(0.94 to 2.54)†

NR Prevalence 

of condom 

use always, 

HIV+

No Hospital inpatients 

and outpatients
184

Category Factor Citation Year

Percentage of Infectedwith FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated 

in Study? Population

Anal-insertive 

sex 

(men only) 

<6 weeks ago

Mehta et 

al.109

2008 7% of 

men

145 

(men 

only)

NR 9,589 1.83

(0.94 to 3.57)†

NR Did not 

have, HIV+

No Hospital inpatients 

and outpatients

Anal-insertive 

sex 

(men only) 

≥6 weeks ago

Mehta et 

al.109

2008 14% of 

men

145 

(men 

only)

NR 9,589 3.32

(2.01 to 5.48)†

NR Did not 

have, HIV+

Yes Hospital inpatients 

and outpatients

Anal-insertive 

sex 

(men only) –

Data missing

Mehta et 

al.109

2008 28% of 

men

145 

(men 

only)

NR 9,589 1.43

(0.97 to 2.11)†

NR Did not 

have, HIV+

No Hospital inpatients 

and outpatients

Anal-receptive 

sex <6 weeks 

ago

Mehta et 

al.109

2008 2% 229 NR 16,467 2.29

(0.93 to 5.65)†

NR Did not 

have, HIV+

No Hospital inpatients 

and outpatients

Anal-receptive 

sex ≥6 weeks 

ago

Mehta et 

al.109

2008 6% 229 NR 16,467 6.56

(3.73 to 11.5)†

NR Did not 

have, HIV+

Yes Hospital inpatients 

and outpatients

Anal receptive 

sex –

Data Missing

Mehta et 

al.109

2008 21% 229 NR 16,467 1.70

(1.23 to 2.34)†

NR Did not 

have, HIV+

Yes Hospital inpatients 

and outpatients

Vaginal sex 

<6 weeks ago

Mehta et 

al.109

2008 43% 229 NR 16,467 0.33

(0.22 to 0.50)†

NR Did not 

have, HIV+

No 

(protective)

Hospital inpatients 

and outpatients
185

Category Factor Citation Year

Percentage of Infectedwith FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated 

in Study? Population

Vaginal sex 

≥6 weeks ago

Mehta et 

al.109

2008 32% 229 NR 16,467 0.49

(0.32 to 0.74)†

NR Did not 

have, HIV+

No 

(protective)

Hospital inpatients 

and outpatients

Vaginal sex –

Data Missing

Mehta et 

al.109

2008 21% 229 NR 16,467 0.56

(0.33 to 0.95)†

NR Did not 

have, HIV+

No 

(protective)

Hospital inpatients 

and outpatients

Non-injection Drugs

Ever used 

cocaine/street 

drugs

McQuillan et 

al.101

2006 47% 30 21% 4,938 3.3

(1.6 to 6.9)†¶

<0.001 Proportion in 

HIV+ vs. 

HIVYes General population

Crack cocaine 

use

Alpert et 

al.115

1996 NR 35 NR 840 NR‡ SS Proportion in 

HCV+ vs. 

HCVYes Adults at emergency 

department room

Alcohol and/or 

drug problem 

(as identified 

in health care 

database)

Fischer et 

al.114

2000 36% 11 12% 1,369 12.5

(2.3 to 69.0)†

0.004 Proportion in 

HCV+ vs. 

HCVYes Adults enrolled in 

HMO

* Odds ratios as reported in publication, unless otherwise specified

** As reported in publication, unless otherwise specified

† Univariate, unadjusted

‡ Multivariate, adjusted for other factors

¶ Calculated by ECRI Institute
186

Table 36. GRADE Table for Question 3 (Behavioral Risk Factors)

Factor Virus

Quantity and 

Type of Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall Q

Outcome

uality

ConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose ResponseAssociated Despite Confounders

Factors Identified in Original Guideline Men who have Sex with Men (MSM)

HBV 2 OBS29,124 HBV was significantly associated with MSM in 

univariate analyses in two studies, one on the 

general population and one on college students. 

The college students study also performed an 

multivariate analysis and the association 

remained significant.124

Low 0 0 0 0 0 1 0 0 Moderate

HCV 2 OBS105,112 One blood donor study found a significant 

association between HCV and MSM upon 

univariate but not multivariate analysis.105

A general population study found no association 

at all in univariate analysis.112

Low 0 -1 0 0 0 0 0 0 Very Low

HIV 2 OBS101,110 HIV infection was significantly associated with 

MSM in the general population in two univariate 

analyses.

Low 0 0 0 0 0 1 0 0 Moderate
187

Factor Virus

Quantity and 

Type of Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall Q

Outcome

uality

ConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose ResponseAssociated Despite Confounders

Injection Drug Users (IDU)

HBV 5 OBS116,121,124-126 HBV was significantly associated with IDU in 

four studies, one of the general population116 and 

three of special populations.121,124,125 Three of 

these studies had large effect sizes, and the 

fourth came close.124 The fifth study, another 

special population study, did not find any 

association. This may be a statistical anomaly 

due to the very low prevalence of HBV and IDU 

in this obstetric population.126 The general 

population study and one of the special population 

studies125 performed multivariate analyses, the 

rest were univariate.

One of the special population studies also 

considered steroid injection but did not find a 

significant relationship.124

Low 0 0 0 0 0 0 0 0 Low

HCV 7 OBS30,104-

106,112,114,116

Three blood donor studies104-106 and four general 

population studies30,112,114,116 detected 

associations between IDU and HCV. All of these 

studies found large effect sizes. Two of the blood 

donor studies and three of general population 

studies30,112,116 performed multivariate analyses 

and determined IDU is an independent risk factor 

(the other studies performed univariate 

assessments only).

One of the blood donor studies also considered 

past steroid injection use and did not find a 

significant association with HCV.104

Low 0 0 0 0 0 1 0 0 Moderate
188

Factor Virus

Quantity and 

Type of Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall Q

Outcome

uality

ConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose ResponseAssociated Despite Confounders

HIV 3 OBS101,109,110 All three studies assessed IDU in the general 

population in univariate analyses. Two found a 

significant association with large effect sizes,101,110

and the third did not find any association.109

Low 0 0 0 0 0 0 0 0 Low

Sex Work

HBV 3 OBS103,121,125 None of the studies found an association between 

sex work (including sex bartering or sex for drugs) 

and HBV; however, one was a very low-quality 

tissue donor study based upon next-of-kin 

interviews,103 and the other two studied special 

populations.121,125

Low 0 0 -1 0 0 0 0 0 Very Low

HCV 4 OBS103,105,112,113 The very low-quality tissue donor study based 

upon next-of-kin data did not detect any 

association between HCV and sex work. The 

remaining three studies did. One multivariateanalysis blood donor study105 and two univariateanalysis general populations studies112,113 did 

detect significant associations.

Low 0 0 0 0 0 0 0 0 Low

HIV 1 OBS103 The very low-quality tissue donor study based 

upon next-of-kin data did not detect any 

association between HCV and sex work.

Low -1 -1 0 -1 0 0 0 0 Very Low
189

Factor Virus

Quantity and 

Type of Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall Q

Outcome

uality

ConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose ResponseAssociated Despite Confounders

High-risk Sex Partners: IDUs

HBV 4 OBS116,117,121,124 In a multivariate analysis in the general 

population, having a sex partner IDU was 

significantly associated with HBV.116 In another 

general population study, recent sex or household 

contact with an IDU was associated with recent 

HBV infection.117 In univariate analysis it was 

significantly associated with HBV in one special 

population study124 but in not another.121

Low 0 -1 0 0 0 0 0 0 Very Low

HCV 4 OBS104,105,113,116 A univariate investigation of blood donors,105

a multivariate investigation of blood donors,104

a univariate investigation of people in the general 

population,113 and a multivariate investigation in a 

general population116 all found a significant 

relationship between HCV and having sex with an 

IDU. In all four studies the effect size was large.

Low 0 0 0 0 0 1 0 0 Moderate

HIV No Studies 

Identified

- - - - - - - - - - NA

High-risk Sex Partners: 

Sex Worker

HBV 1 OBS121 Sex with a sex worker was not associated with 

HBV in a special population study.121

Low 0 -1 -1 -1 0 0 0 0 Very Low

HCV 3 OBS105,112,113 Sex with a sex worker was associated with HCV 

in a multivariate analysis of blood donors105 and 

in two univariate analyses of general 

populations.112,113 However, one of those general 

population studies also performed a multivariate 

analyses and did not detect a relationship.112

Low 0 -1 0 0 0 0 0 0 Very Low
190

Factor Virus

Quantity and 

Type of Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall Q

Outcome

uality

ConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose ResponseAssociated Despite Confounders

HIV No Studies 

Identified

- - - - - - - - - - NA

High-risk Sex Partners: People with Known 

Infection

HBV 2 OBS124,126 Of the two univariate analyses of special 

population studies, one study found a significant 

relationship between having a sexual partner with 

hepatitis and having HBV,124 while the other 

did not.

126

Low -1 -1 -1 -1 0 0 0 0 Very Low

HCV 2 OBS104,105 Two studies of blood donors, one with a 

multivariate analysis105 and one with a univariate 

analysis,104 found significant associations 

between having a sex partner with hepatitis and 

having HCV.

Low 0 0 0 0 0 0 0 0 Low

HIV 1 OBS109 On general population study performed a 

univariate analysis and found that the relationship 

between having a sex partner with HIV and 

having HIV was significant and large.109

Low -1 0 0 0 1 0 0 Low

Incarceration

HBV 4 OBS103,117,121,124 The tissue donor study based upon next-of-kin 

interview did not associate HBV with a history of 

incarceration.103 Upon univariate analyses, 

one general population study117 and two special 

population studies did find a significant 

association.121,124 However, the general 

population study also performed a multivariate 

analysis and did not find an association.117

Low 0 -1 0 0 0 0 0 0 Very Low
191

Factor Virus

Quantity and 

Type of Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall Q

Outcome

uality

ConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose ResponseAssociated Despite Confounders

HCV 4 OBS103-106,113 The tissue donor study based upon next-of-kin 

interview did not associate HCV with a history of 

incarceration.103 Three blood donor studies104-106

found an association between HCV and history of 

incarceration, and of the two that performed 

multivariate analysis,105,106 one found it was an 

independent risk factor.105 Having ever been 

arrested was associated with HCV in the general 

population study.113

Low 0 0 0 0 0 0 0 0 Low

HIV 1 OBS103 The tissue donor study based upon next-of-kin 

interview did not associate HIV with a history of 

incarceration.103

Low -1 -1 0 -1 0 0 0 0 Very Low

Additional Potential Risk Factors Identified in the 2009 Literature Search Sex with Multiple Partners

HBV 5 OBS 

29,116,117,124,125

Various definitions of having multiple partners 

were associated with HBV in three general 

population studies29,116,117 and two special 

population studies.124,125 In all but one of these 

studies124 multivariate analyses were performed.

Low 0 0 0 0 0 0 1 0 Moderate
192

Factor Virus

Quantity and 

Type of Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall Q

Outcome

uality

ConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose ResponseAssociated Despite Confounders

HCV 6 OBS 

30,104,105,113,114,116

As was the case for HBV, the studies testing the 

association of this factor with HCV defined 

“multiple” using different thresholds. A blood donor 

study found that having multiple partners was a 

risk factor for HCV among women but not men in a 

multivariate analysis.105 The remaining 5 studies 

are all general population studies that performed 

univariate analyses and found associations 

between having multiple sex partners and having 

HCV.30,104,113,114,116

Low 0 0 0 0 0 0 1 0 Moderate

HIV 3 OBS101,109,110 All 3 studies performed univariate analyses on 

general populations using different definitions for 

“multiple” partners. The study with the highest 

threshold for defining “multiple” (>50) found an 

association with HIV,101 while the other two studies 

(one investigating having at least 10 lifetime109

partners and other investigating having “multiple” 

partners in the past year) did not.110

Low 0 -1 0 0 0 0 1 0 Low

Same-Sex Partners, Not 

Restricted to MSM

HBV No studies - - - - - - - - - - NA

HCV 2 OBS105,113 One blood donor study found a significant 

association between women who have sex with 

women and HCV infection, but in multivariate 

analysis this was only significant if the woman had 

had 2 or more same-sex partners. One general 

population study did not find an association 

between same-sex partners, not limited to MSM, 

in a univariate analysis.113

Low 0 -1 0 -1 0 0 0 0 Very Low
193

Factor Virus

Quantity and 

Type of Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall Q

Outcome

uality

ConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose ResponseAssociated Despite Confounders

HIV 1 OBS109 One general population study did detect an 

association between HIV and having a same-sex 

sex partner in a univariate analysis.109

Low 0 -1 0 0 0 1 0 0 Low

Age at First Sexual Intercourse

HBV 2 OBS29,124 Age of 18 years or younger was not associated 

with HBV in general population multivariate 

analysis.29 Age at first intercourse of 15 years or 

younger was associated with HBV infection in a 

special population univariate analysis.124

Low 0 -1 0 0 0 0 1 0 Low

HCV 1 OBS30 In the general population, age of 17 years or 

younger was associated with HCV in a univariate 

analysis.30 In that study, the size of effect was 

larger for people who were younger than 11 or 12-

15 than for those 16-17 years old.

Low 0 -1 0 0 0 0 1 0 Low

HIV 1 OBS101 Age of 18 years or younger was associated with 

HIV in a univariate analysis of a general 

population.101

Low 0 -1 0 0 0 1 0 0 Low

Non-injection 

Illicit Drugs

HBV 5 OBS

29,103,121,124,125

HBV was not associated with illicit non-injection 

drugs in the tissue donor study103 or two special 

population studies.121,125 A multivariate general 

population analysis29 and univariate special 

population analysis124 did find associations. 

Low 0 -1 0 0 0 0 0 0 Very Low
194

Factor Virus

Quantity and 

Type of Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall Q

Outcome

uality

ConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose ResponseAssociated Despite Confounders

HCV 8 OBS30,103-106,112-

114

The tissue donor study did not find an association 

between HCV and drug use as reported by next of 

kin.103 Three blood donor studies did associate 

HCV with noninjection drug use,104-106 including in 

multivariate analyses in two of them.105,106 In a 

general population univariate analyses, use of 

snorting or inhaling nonprescription drugs,113

inhaling cocaine,114 using intranasal cocaine,112

and use of non-injection drugs other than 

marijuana30 were all associated with HCV. 

Two of these studies performed multivariate 

analyses,30,112 and one did not find the factor to 

be an independent predictor of HCV.112

Low 0 0 0 0 0 0 0 0 Low

HIV 2 OBS101,115 HIV was associated with ever using cocaine or 

street drugs in a univariate analysis101 and in a 

multivariate analysis115 among members of the 

general population.

Low 0 0 0 0 0 0 0 0 Low

Alcohol

HBV 2 OBS103,125 HBV was not associated with alcohol use in a 

univariate analysis of tissue donors103 or alcohol 

use disorder in a multivariate analysis of a special 

population.125

Low 0 0 0 -1 0 0 0 0 Very Low

HCV 5 OBS102,103,112-114 HCV was associated with “heavy” alcohol use in 

heart donors102 and with having at least two units 

of alcohol per day in a general population.112

HCV was not associated with alcohol use among 

tissue donors103 or having at least 5 alcoholic 

drinks weekly113 or alcoholism114 in general 

populations. All of these analyses were univariate.

Low 0 -1 0 0 0 0 0 0 Very Low
195

Factor Virus

Quantity and 

Type of Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall Q

Outcome

uality

ConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose ResponseAssociated Despite Confounders

HIV 2 OBS103,114 HIV was associated with having an alcohol and/or 

(unspecified) drug problem in a general 

population114, but not with alcohol use among 

potential tissue donors.103 Both of these analyses 

were univariate.

Low 0 -1 0 -1 0 0 0 0 Very Low

Tobacco

HBV 1 OBS103 No association was found between cigarette 

smoking and HBV among tissue donors.103

Low -1 -1 0 -1 0 0 0 0 Very Low

HCV 2 OBS102,103 A history of tobacco use was associated with HCV 

in heart donors,102 and cigarette smoking was 

associated with HCV in tissue donors.103 Both of 

these associations were made using univariate 

analyses. 

Low -1 0 0 0 0 0 0 0 Very Low

HIV 1 OBS103 No association was found between cigarette 

smoking and HIV among tissue donors.103

Low -1 -1 0 -1 0 0 0 0 Very Low

Tattoos and Piercing

HBV 5 OBS 

103,117,121,124,126

Tattoos, piercing, and acupuncture (as collectively 

analyzed as one outcome and reported by next-ofkin) were not associated with HBV in tissue 

donors.103

Tattoos were not associated with HBV in one 

general population study117 or three special 

population studies.121,124,126

Piercings were not associated with HBV in one 

general population study117 or two special 

population studies.121,124

All analyses were univariate.

Low 0 0 0 0 0 0 0 0 Low
196

Factor Virus

Quantity and 

Type of Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall Q

Outcome

uality

ConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose ResponseAssociated Despite Confounders

HCV 7 OBS103-106,112-114 Tattoos, piercing, and acupuncture (as collectively 

analyzed as one outcome and reported by next-ofkin) were not associated with HBV in tissue 

donors.103

3 blood donor studies104-106 and three general 

population studies112-114 detected significant 

associations between tattoos and HCV. Three 

performed multivariate analyses, and one found 

that tattoos were not an independent predictor106

while the other two did.105,112

Of 3 blood donor studies, HCV was associated 

with ear piercing among men in one study106 and 

pierced ears or body parts in another105in 

multivariate analyses, but not recent body piercing 

in a third with univariate analysis.104

In univariate analyses of general populations, HCV 

was not associated with body piercing in two 

studies112,114 but was associated with ear piercing 

in a third study.113

Low 0 0 0 0 0 0 0 0 Low

HIV 1 OBS103 Tattoos, piercing, and acupuncture (as collectively 

analyzed as one outcome and reported by next-ofkin) were not associated with HBV in tissue 

donors.103

Low -1 -1 0 -1 0 0 0 0 Very Low
197

Factor Virus

Quantity and 

Type of Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall Q

Outcome

uality

ConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose ResponseAssociated Despite Confounders

International Travel

HBV 2 OBS103,117 International travel was not associated with HBV 

among tissue donors103 or with recent HBV 

infection in a general population.117

Low 0 0 0 -1 0 0 0 0 Very Low

HCV 3 OBS103-105 International travel was not associated with HCV 

among tissue donors.103 In blood donors neither 

recent travel outside the U.S.104 nor ever having 

lived outside the U.S.105 was associated with HCV.

Low 0 0 0 0 0 0 0 0 Low

HIV 1 OBS103 International travel was not associated with HIV 

among tissue donors.103

Low -1 -1 0 -1 0 0 0 0 Very Low
198

Table 37. Prevalence of Behavioral Risk Factors

Category Risk Factor Citation Year Prevalence N = in population Population

Potential and Actual Organ Donors Drug 

Abuse

Unspecified ongoing 

substance abuse

Hidalgo et al.8 2001 5.5% 55 Parental potential living donors to their children

Alcohol

Heavy alcohol use Gasink et al.102 2006 20% 10,915 Actual organ (heart) donors

Tobacco

History of tobacco use Gasink et al.102 2006 36% 10,915 Actual organ (heart) donors

General Population Men who have Sex with Men

Male-to-male sex McQuillan et al.101 2006 3.7% 2,439 men General population

Men who have sex with men, 

history of

Nguyen et al.110 2008 9.3% 590 men General population in N.Y.C.

Injection Drug

Use

Ever used a needle for drugs Nguyen et al.110 2008 1.4% 1,505 General population in N.Y.C.

Lifetime injection drug use 

(participants aged 20-59)

Armstrong et al.30 2006 1.7% 5,368 General population, nationwide

Injection drug use Mehta et al.109 2008 7.9% 16,696 Patients in urban medical care center

Injection drug use Kaur et al.116 1996 3.5% 7,538 Volunteers from general population, 

mainly urban

No use of needle exchange 

program among injection drug 

users

Mehta et al.109 2008 63.2% 1,258 Patients in medical care center

Sex Work

Exchanged sex for money or 

drugs

Mehta et al.109 2008 2.3% 16,696 Patients in an urban medical care center
199

Category Risk Factor Citation Year Prevalence N = in population Population High-risk Sex 

Partners

Sexual partner with HIV Mehta et al.109 2008 3.6% 16,696 Patients in urban medical care center

Sex with IV drug user Kaur et al.116 1996 5% 6,562 Volunteers from general population, mainly 

urban

Sex with a commercial sex 

worker

Mehta et al.109 2008 7.4% 16,696 Patients in an urban medical care center

Additional Sex Practices

Sex with same or both 

genders (asked both men and 

women)

Mehta et al.109 2008 8.2% 15,586 Patients in urban medical care center

Lifetime number of sexual 

partners 10+ 

(participants aged 18-59)

Armstrong et al.30 2006 29% 5,357 General population, nationwide

Lifetime number of sexual 

partners 2+

McQuillan et al.101 2006 74% 5,391 General population, nationwide

Lifetime number of sexual 

partners 2-49

Nguyen et al.110 2008 74% 1,469 General population in N.Y.C.

Lifetime number of sexual 

partners 50+

McQuillan et al.101 2006 3.5% 5,391 General population, nationwide

Lifetime number of sexual 

partners 50+

Nguyen et al.110 2008 6.6% 1,469 General population in N.Y.C.

Sex with multiple partners Kaur et al.116 1996 26% 7,325 Volunteers from general population, mainly 

urban

Sex with multiple partners 

during previous year

Nguyen et al.110 2008 22% 1,368 General population in N.Y.C.

Age at first intercourse 

younger than 18 years 

(participants aged 18-59)

Armstrong et al.30 2006 58% 5,054 General population, nationwide
200

Category Risk Factor Citation Year Prevalence N = in population Population

Age at first intercourse 

younger than 18 years

McQuillan et al.101 2006 59% 5,373 General population, nationwide

Noninjection 

Substance

Abuse

Lifetime drug use 

other than marijuana 

(participants aged 20-59)

Armstrong et al.30 2006 17% 5,683 General population, nationwide

Ever used cocaine/

street drugs

McQuillan et al.101 2006 21% 4,969 General population, nationwide

Ever used drugs, any Nguyen et al.110 2008 18% 1,505 General population in N.Y.C.
201

Table 38. GRADE Table for Question 3: Prevalence of Behavioral Risk Factors

Factor

Quantity and Type of 

Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE of 

Evidence 

for 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Outcome

-response

Associated Despite Confounders

Men who have 

sex with men

2 OBS*101,110 In two general population studies, one 

reported that 3.7% of men have sex with 

another man,101 while the other reported 

that 9.3% have a history of having sex 

with another man.128

High 0 -1 -1 0 0 0 0 0 Low

Injection drug 

abuse

4 OBS30,109,110,116 All four studies assessed general 

populations. Reported prevalences of 

injection drug use were 1.4%,110 1.7%,30

3.5%,116 and 7.9%.109 The lower two 

estimates were derived from NHANES 

data, and the higher two were drawn 

from patients and volunteers in urban 

areas.

(Of the injection drug users in one study, 

63.2% reported they did not use needle 

exchange programs.109 )

High 0 -1 -1 0 0 0 0 0 Low

Sex Work 1 OBS109 One general population study reported 

2.3% of participants reported 

exchanging sex for money or drugs.109

High 0 -1 -1 0 0 0 0 0 Low

High-Risk Sex 

Partners: 

Injection drug 

user

1 OBS116 Among general population volunteers 

from a mainly urban area, 5% reported 

having sex with an injection drug use.116

High 0 -1 -1 0 0 0 0 0 Low
202

Factor

Quantity and Type of 

Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE of 

Evidence 

for 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Outcome

-response

Associated Despite Confounders

High-Risk Sex 

Partners: Sex 

workers

1 OBS109 In the same population, 7.4% reported 

sex with a commercial sex worker.109

High 0 -1 -1 0 0 0 0 0 Low

Multiple Sex 

Partners: 

Multiple 

undefined

2 OBS110,116 26% of volunteers in one study reported 

having sex with multiple partners,116

while 22% of NHANES participants 

reported having multiple sex partners 

during the previous year.110

High 0 0 -1 0 0 0 0 0 Moderate

Multiple Sex 

Partners: At 

least 2 partners

2 OBS101,129 74% reported having sex with at least 

two partners,101 74% reported having 

sex with 2-49 partners.110

High 0 0 -1 0 0 0 0 0 Moderate

Multiple Sex 

Partners: At 

least 50 partners

2 OBS101,110 In one study, 3.5% reported having at 

least 50 sex partners,101 while in another 

6.6% did.110

High 0 -1 -1 0 0 0 0 0 Low

Age at first 

intercourse (<18 

years)

2 OBS30,101 The proportion of adults who reported 

having sex at age 18 or younger were 

58%30 and 59%101 in two general 

population studies.

High 0 0 -1 0 0 0 0 0 Moderate

Same-sex 

partner (not 

restricted to 

men)

1 OBS109 8.2% of men and women reported 

having sex with same or both 

genders.109

High 0 -1 -1 0 0 0 0 0 Low

Noninjection 

substance 

abuse: Ongoing

1 OBS8 Among potential living donors, 5.5% had 

unspecified ongoing drug abuse.8

High 0 -1 0 -1 0 0 0 0 Low
203

Factor

Quantity and Type of 

Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE of 

Evidence 

for 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Outcome

-response

Associated Despite Confounders

Noninjection 

substance 

abuse: Lifetime

3 OBS30,101,110 In the general population, 17% reported 

lifetime use of drugs other than 

marijuana,30 18% reported ever having 

used any drugs,110 and 21% reported 

ever using street drugs/cocaine.101

High 0 0 -1 0 0 0 0 0 Moderate

Alcohol 1 OBS102 Among heart donors, 20% reportedly 

drank alcohol heavily.102

High -1 -1 0 0 0 0 0 0 Low

Tobacco 1 OBS102 Among heart donors, 36% reportedly 

used tobacco.102

High -1 -1 0 0 0 0 0 0 Low

*Observational study
204

Question 4: Results

In this section, data on nonbehavioral potential risk factors including signs and symptoms indicative of 

infection, potential exposure, co-morbidities, and demographic factors are presented. Information 

regarding exclusionary factors listed in the 1994 guideline is presented first, and then information 

regarding additional factors for which at least two studies provided evidence regarding the same factor is 

presented. All of the data related to the identification of risk factors is provided in Table 39 (HBV), 

Table 40 (HCV), Table 41 (HIV), and Table 42 (GRADE tables). Prevalence information is provided in 

Table 43.

Exclusionary Criteria from 1994 Guideline

People with Hemophilia or Related Clotting Disorder who Received Clotting Factor Blood Products

The 1994 guideline excludes from donating “Persons with hemophilia or related clotting disorders who 

have received human-derived clotting factor concentrates.” We identified zero studies that studied 

whether this factor was associated with an increased prevalence of infection. This may be due to the 

relative rarity of having hemophilia or a related blood clotting disorder in the populations included in the 

evidence base for these questions. However, we did identify a large number of studies that considered the 

association between blood transfusions and infection regardless of any underlying disease. For more 

information, see Receipt of Blood Transfusion under Risk Factors Identified in the 2009 Literature 

Search.

Exposure to Infected or Suspected Blood

The 1994 guideline excludes from donating “Persons who have been exposed in the preceding 12 months 

to known or suspected HIV-infected blood through percutaneous inoculation or through contact with an 

open wound, nonintact skin, or mucous membrane.”

Only one of the studies specifically inquired as to whether patients had been exposed to blood known or 

suspected to be infected. Among embalmers, Turner et al. did not find an association between needlestick 

injury with exposure to recognized HBV infection during embalming and HBV infection.127

GRADE Summary: This evidence is rated as “very low” because of indirectness, imprecision, and lack of 

consistency.

Many of the studies did, however, ask about exposure to blood in general, including by needlestick 

injuries and in other accidents. See Nonspecific exposure below for information on these factors. 

Children

The nonbehavioral exclusion criteria for children are the same as listed in Question 3. We did not identify 

any information regarding the two (above) nonbehavioral exclusion criteria in children or in children of 

mothers with such factors, or any other clinical factors.
205

Additional Potential Risk Factors Identified in the 2009 Literature Search

In addition to the factors identified in the 1994 guideline, we extracted data on all other reported risk 

factors identified in the literature. The following sections describe the evidence regarding the various 

factors and infection reported by at least two studies.

Signs and Symptoms

An objective of this section was to identify nonbehavioral factors that could be predictive of infection, 

especially acute infection during the window period before diagnostic tests could recognize the infection. 

However, extremely little data on such signs and symptoms were identified. 

The only signs identified were associated with HCV infection. In blood donors, alanine aminotransferase 

(ALT) reactivity was associated with infection by Orton et al.104 In a general young adult population 

(aged 18 to 49), serum ALT of >40 U/L was associated with HCV by Armstrong et al.30 “Elevated liver 

enzyme” was associated with HCV in adults comprising individuals at risk for HCV, and healthcare 

workers enrolled in a health maintenance organization (HMO) in Fischer et al.114 In addition, jaundice 

was associated with HCV in adults in a general medical clinic by Nguyen et al.113

GRADE Summary: Although several signs were reported, they are all different and therefore must be 

considered in isolation. The association of HCV with jaundice, ALT reactivity, and elevated ALA were 

large effect sizes and therefore rated as low. The effect size for “elevated liver enzyme” was not large, 

and therefore rated as very low. 

Prevalence: In a general population, 9% of survey respondents had ALT >40 U/L.30

GRADE Summary of Prevalence: The prevalence estimate was rated as low due to indirectness and lack 

of proof of consistency.

Receipt of Blood Transfusion

Although no studies reported on risk in people with clotting disorders or who have received clotting factor 

blood products, many did investigate risk of infection associated with blood transfusion. Two of three 

studies associated blood transfusion with HBV, and all eight studies associated it with HCV. 

HBV: Blood transfusion was associated with HBV infection in a general population in Kaur et al.,116

as was blood transfusion before 1991 among college students in Hwang et al.124 Blood transfusion was 

not associated with HBV in the low prevalence obstetric patients study by Butterfield et al. (1990).126

HCV: All 8 studies that looked at this factor did find some association with transfusion and HCV 

infection. Receiving a blood transfusion was independently associated with HCV in three studies of blood 

donors, Conry-Cantilena et al.,106 Murphy et al. (2000),105 and Murphy et al. (1996).107 In Murphy et al. 

(2000), the association was only significant among donors who had never injected drugs.105

In three studies of the general population, blood transfusion was associated with HCV by Nguyen et al.,113

Hand and Vasquez,112 and Kaur et al.,116, and in the two studies that calculated multivariable models,112,116

the association was independent. In the general population, Armstrong et al. found that the relationship 

between HCV and blood transfusion before 1992 was independent,30 and Fischer et al. detected an 

association but did not test whether the risk factor was independent.114 Sex with a blood transfusion 

recipient was also associated with HCV infection in Murphy et al. (2000).105
206

Some studies combined having received a blood transfusion with other outcomes. Being a blood 

transfusion recipient or donor (data not reported separately) as reported by next-of-kin was not associated 

with an increased risk of HBV, HCV, or HIV among potential tissue donors by Sanchez et al.103 Either 

receiving a blood transfusion or having a household contact with a person who had was not associated 

with acute HBV by Alter et al.117 We did not consider these outcomes sufficiently similar to group with 

receipt of blood transfusion only.

GRADE Summary: The evidence for HBV was mostly indirect, and downgraded to very low rating 

accordingly. For HCV, the evidence consistently pointed to an association with transfusion with large 

magnitude, and was rated as moderate.

Prevalence: Among general population survey respondents, 6% of those aged 20 to 59 years (in 2006) 

reported having a blood transfusion before 1992, and 16% of those aged at least 60 years did.30 Among 

volunteers from an urban area, 20% reported having ever had a blood transfusion.116

GRADE Summary of Prevalence: The evidence of these prevalence estimates were rated as low due to 

indirectness and lack of proof of consistency.

Nonspecific Exposure

Although only one study asked participants whether they had ever been exposed to infected or potentially 

infected blood, many studies asked about exposure to blood without regard to any knowledge about the 

infection status of the blood. Besides hemodialysis, most of these factors were not found to be 

consistently associated with infection.

Accidental Needle Stick

According to data collected from next-of-kin, accidental needle sticks were not associated with HBV, 

HCV, or HIV among potential tissue donors in Sanchez et al.103

In a general population study by Kaur et al., needlestick injuries were actually associated with lower 

prevalence of HBV and HCV infection.116 This may be because a substantial proportion of the enrollees 

were healthcare workers, and in that study healthcare workers had a lower prevalence of HBV than the 

group as a whole. Needlestick injuries among healthcare worker blood donors in Conry-Cantilena et al. 

were not associated with HCV either.106 However, “bloody” needlestick injuries in a medical setting was 

associated with an increased prevalence of HCV in Murphy et al. (2000).105

GRADE Summary: For all three viruses this evidence was rated as “very low.” For HBV this was due to 

lack of precision, for HCV it was due to inconsistency, and for HIV it was due to low quality, 

imprecision, and lack of consistency.

Hemodialysis

Most studies found an association between hemodialysis and HBV or HCV. Hemodialysis was associated 

with HBV among volunteers from the general population by Kaur et al.116 and among college students by 

Hwang et al.124 In studies that enrolled people from the general population, HCV infection was associated 

with hemodialysis in Kaur et al.,116 and with “kidney dialysis” in Nguyen et al,113 but not with 

hemodialysis in Hand and Vasquez.

112 The duration of administration of dialysis was not specified.
207

GRADE Summary: The evidence associating HBV with hemodialysis was rated as “moderate” because 

the size of the association in the special population was large. For HCV, strength of evidence was low.

Surgery

The relationship between surgery and infection was inconsistent. Based upon next-of-kin data for 

potential tissue donors, Sanchez et al. did not find any associations between HBV, HCV, or HIV and 

surgeries.103 In the general population, surgery was associated with a lower HBV prevalence by 

Kaur et al.,116 and surgery during the last six months was not associated with acute HBV in Alter et al.117

Having surgery or a medical procedure in the six months before blood donation was not associated with 

HCV in Orton et al.,104 and having a history of surgery was not associated with HCV in general

population studies by Fischer et al.114 or Kaur et al.116 However, lifetime history of surgery or sutures was 

associated with elevated HCV prevalence in blood donors in Murphy et al. (2000).105

GRADE Summary: For all three viruses, the evidence was inconsistent and rated as “very low.” For HIV 

the evidence base was also of very low quality and imprecise.

Organ and Corneal Transplantation Recipients

No organ transplantation studies were identified that met the inclusion critiera. Receipt of corneal 

transplantation was not associated with a greater risk of HBV, HCV, or HIV in the tissue donor study by 

Sanchez et al.103, or with HBV among psychiatric inpatient veterans in the study by Tabibian et al.121

GRADE Summary: For all three viruses, the evidence was rated as very low due to imprecision. For HCV 

and HIV the evidence was also of very low quality with no proof of consistency.

Acupuncture

Acupuncture during the last six months was not associated with an increased incidence of acute HBV in 

Alter et al.117 or increased prevalence of HBV among psychiatric inpatient veterans in Tabibian et al.,121

or with HCV among blood donors in Conry-Cantilena et al.106 or Murphy et al.,107 or people in a general 

population in Hand and Vasquez et al.112

GRADE Summary: For both HBV and HCV, the GRADE was not decreased and the evidence was rated 

as low.

Dental Work

Dental work within the last six months was not associated with acute HBV in Alter et al.117 Dental work 

was not associated with HCV among blood donors in Murphy et al.105; nor was having dental work in the 

six months before donation in Orton et al.104

GRADE Summary: For HBV, the evidence was downgraded due to imprecision and rated as very low. For 

HCV, the evidence was not downgraded and was rated as low.

Blood Draws

Blood draws should not expose patients to blood (and is probably a proxy for other risk factors). 

Sanchez et al. did not find an association between HIV testing and HIV, HBV, or HCV among tissue 

donors, based upon next-of-kin interviews.103 However, Nguyen et al. (2005) did find an association 

between having had a blood test for HBV and having an HCV infection in a univariate analysis of adults 

in the general population.113 Similarly, being a blood donor should not pose a direct infectious risk. In the 
208

same study, Nguyen et al. found that being a blood donor was associated with reduced risk of HCV, and 

that having been rejected as a blood donor was associated with an increased risk of HCV.113

GRADE Summary: Because evidence was imprecise for each of the viruses and also inconsistent for HBV 

and HIV, the evidence regarding blood draws was rated as “very low.”

Other Blood Exposure

Neither bloody object contact in Tabibian et al.121 nor combat exposure in Butterfield et al. (2004)125 were 

associated HBV among psychiatric inpatient veterans. Having been “stuck” or “cut” with a blood object 

was independently associated with HCV among blood donors in Murphy et al. (2000)107 Among blood 

donors in Orton et al.104 blood exposure during fighting, by biting, at an accident site, or during a 

manicure in the last six months was associated with HCV, but not during a haircut in the last six months. 

Contact with blood was not associated with HCV in members of a general population study by Hand and 

Vasquez.112

We report these factors here because of their relevance but did not rate the GRADE for these “other” 

outcomes due to lack of replication of the various factors.

Household Exposure

Whether hepatitis infection among other household members was a risk factor for exposure was 

investigated in several studies, with inconsistent findings. Having household contact with someone with 

hepatitis was associated with HBV among college students in Hwang et al.124, as was a family history of 

HBV among Asian Americans in Lin et al.123 Having a household member with hepatitis was not 

associated with HBV in an obstetric population in Butterfield et al.;126 nor was being the wife of a man 

with HBV among Korean American church goers in Hann et al.122 Among blood donors in Murphy et al., 

living with someone with hepatitis or having a relative with hepatitis was not associated with HCV 

infection, but living with a transfusion recipient was.105 In general population studies, having at least 

one family member treated for viral hepatitis was not associated with an increased risk of HCV in 

Fischer et al.,114 but having at least one family member with HCV was in Nguyen et al.113

Sharing a razor or toothbrush with another household member was not associated with HBV members of 

the general population in Alter et al.117 However, sharing a toothbrush or razor with person(s) unspecified 

was associated with HCV among blood donors in Murphy et al.105

GRADE Summary: All of the evidence pertaining to household exposure and HBV and HCV infection 

was inconsistent, and therefore rated as very low. For HBV the evidence was also indirect: all of it came 

from special population studies.

Other Infections

Sexually transmitted infections were nearly universally associated with increased risk of HBV, HCV, or 

HIV. HBV surface antigen positivity was associated with HCV infection among heart donors in Gasink et 

al.102 Among college students, HBV infection was associated with having had a sexually transmitted 

disease (STD) in Hwang et al.124 Among blood donors, HCV was significantly associated with history of 

STD in Conry-Cantilena et al.106 and Murphy et al. (2000),105 and with having a STD within six months 

of donating in Orton et al.,104 and with seropositivity for other reactive infectious diseases in Orton et

al.104 and Murphy et al. (1992).107 Among people from general populations, having past treatment for 
209

STDs was not associated with HCV in Nguyen et al.,113 but having herpes simplex virus (HSV) infection 

was in Armstrong et al.30 HIV infection was not associated with HCV infection upon univariate analysis 

of a general population in Hand and Vasquez.112 Diagnosis of STD in Mehta et al.,109 HSV-2 in 

McQuillan et al. (2006),101 HSV-2 in Nguyen et al.,110 and syphilis or other infection not apparently 

related to HIV in Alpert et al.,115 were all associated with HIV in general populations. Rabies exposure 

was not associated with any of the viruses in the tissue donor study by Sanchez et al.

103

GRADE Summary: For HBV and HIV, the evidence associating them with another infection was rated as 

low. For HCV the evidence was rated as very low due to inconsistency.

Prevalence: Antibodies to HSV-2 were detected in 19% of general nationwide population aged 18 to 

49 years,30 and 28% of New Yorkers.110 STD diagnoses were reported by 18% of patients in an urban 

medical care center.109

GRADE Summary of Prevalence: The estimate of HSV-2 infection was rated as moderate due to 

indirectness. For unspecified STD it was rated as low due to indirectness and lack of proof of consistency.

Demographic Factors

Sex

Male sex was not consistently associated with an increased risk of infection. Males had higher rates of 

HBV than women in studies that considered the general population,116 psychiatric inpatient veterans 

(of whom nearly all were male),121 and Asian Americans,123 but not Korean American church goers.120

Among college students124 females had higher rates of HBV, and among children who had received a 

blood transfusion, in Luban et al., rates were not significantly different.118 Among heart transplant donors, 

being male was associated with an increased risk of HCV.102 In one study of blood donors, being male 

was associated with an increased risk of HCV,107 but among two others it was not.104,106 In four general 

population studies, significantly higher proportions of males had HCV infection in four30,108,113,116 out of 

five studies.114 Male sex was not associated with HIV in three general population studies.109-111

GRADE Summary: For HBV and HCV, the evidence was rated as very low due to inconsistent findings.

For HBV, the evidence was also indirect because it was drawn primarily from special population studies.

For HIV, the evidence was rated as low because lack of association was consistently found.

Age

Studies assessed the relationship between age and infection in a variety of different ways. While some 

used mean age, others used various cutoffs (such as older or younger than 30 years) or categorization 

(such as age by decade). Older age was associated with a greater rate of HCV among heart transplant 

donors in Gasink et al.,102 but inconsistently associated with HCV among blood donors, HCV or HIV in 

the general population, or HBV in special subpopulations.

GRADE Summary: Evidence on age was collected using inconsistent methods among studies, clouding 

any potential relationship between age and infection. For HBV the evidence was inconsistent and came 

primarily from special population studies, and was therefore rated as “very low.” The evidence for HCV 

and HIV was also inconsistent and rated as very low.
210

Race or Ethnicity, and National Origin

HBV: Higher HBV prevalence in the general population was associated with non-Hispanic Black 

ethnicity compared with non-Hispanic White ethnicity in McQuillan et al.29 In the same study, being 

Mexican-American was associated with no increase in prevalence compared with being non-Hispanic 

white. In another general population study, the prevalence of HBV was lower among white and Hispanic 

individuals than other races.116 The rest of the studies examined subpopulations. Prevalence was higher 

for African Americans compared to white people among psychiatric inpatient veterans in Butterfield et 

al.125 and among college studentsin Hwang et al.,124 but not among inpatient veterans in Tabibian et al.121

Hispanic or Latino ethnicity was not associated with HBV among psychiatric inpatient veterans in 

Tabibian et al.121 or college students in Hwang et al.124Among college students in Hwang et al., Asian 

students had higher rates of HBV.124

HBV was associated with birth in a Southeast Asian or African country in a general population study by 

Kaur et al.116 but not in a study of Asian Americans by Lin et al.123 Acute HBV was not associated with 

birth in an area with a high endemic rate of HBV or having a household contact with someone who was 

born in an endemic area in Alter et al.117 Among Asian Americans, being born in the U.S. was found to 

be protective in children in Hann et al.122 and in Asian Americans of any age in Lin et al.123 Any 

international birth was associated with increased prevalence of HBV in McQuillan et al.29

HCV: Among heart donors in Gasink et al., ethnicity was not associated with HCV.102 Among blood 

donors, two studies associated increased prevalence with “black” race106,107, and two studies found 

inconsistent relationships between Hispanic ethnicity and HCV.104,107 However, black or Hispanic 

ethnicity was not associated with infection in general population studies,

30,108,113 Orton et al.104 found that 

being born in a country other than the U.S. was associated with HCV among blood donors, but Murphy et 

al.107 did not. McGinn et al. found an association between preferring to speak English or Spanish and 

HCV.108

HIV: HIV was not associated with Asian109,110 or Hispanic ethnicity110,111 but was associated with Black 

ethnicity in two109,110 of three111 studies. Being a Spanish speaker was not associated with prevalence of 

HIV among public emergency room patients in Zetola et al.111

GRADE Summary: All of the evidence regarding race or ethnicity was rated as very low. For HBV this 

was because most of the data came from special subpopulation studies and because some information was 

inconsistent. For HCV and HIV, most studies found no relationship between race or ethnicity and 

infection, but there were some inconsistencies. Very low evidence ratings for national origin/birthplace

and preferred language were assigned for the same reasons.

Occupation

Unemployment was significantly associated with recent HBV infection in the general population in a 

multivariate analysis, in Alter et al.117 Some of the studies investigated whether occupational exposure to 

blood was associated with hepatitis; however, findings were inconsistent. Being a healthcare worker with 

frequent blood exposure was associated with an increased prevalence of HBV in college students in

Hwang et al.124, but being a healthcare worker was not associated with HBV in a general population 

studies by Kaur et al.116 or McQuillan et al.29 or having been a healthcare worker in psychiatric inpatient 

veterans in Tabibian et al.121 or a low-prevalence obstetric population in Butterfield et al.126 Among blood 

donors, occupational blood exposure was associated with HCV infection in Murphy et al.,105 but medical 
211

or dental job or public safety job with frequent blood contact were not in Orton et al.104 In the general 

population, work contact with blood was not associated with increased HCV in Fischer et al.114, and being 

a healthcare worker was actually associated with a lower rate of HCV in Kaur et al.116 Services in the 

armed forces was not associated with HBV in McQuillan et al.29 or with HCV in either Fischer et al.114 or 

Armstrong et al.30 Having a job at a prison was associated with HCV in Nguyen et al.113

GRADE Summary: Most of the occupational information pertained to healthcare workers. Most evidence 

did not associate employment in healthcare with infection. For HBV this finding was consistent and rated 

as low. An additional study considered the association between HBV and military service and did not find 

a relationship and was rated very low for imprecision. For HCV associations with health care job or job 

with blood exposure was inconsistently related with HCV and was rated as very low due to inconsistency 

and imprecision. A lack of association between HCV and serving in the armed forces was found; this 

evidence was rated as very low due to imprecision. Findings associating HCV and working in public 

safety were inconsistent and therefore rated as very low.

Education

Inconsistent evidence suggests lower educational level attainment may be associated with infection. Less 

than a high school education was associated with a higher prevalence of HBV in the general population 

by McQuillan et al.29, but total years of education was not associated with HBV among psychiatric 

inpatient veterans in Tabibian et al.121 College students enrolled in 4-year colleges had lower rates of 

HBV than students enrolled in 2-year colleges in Hwang et al.124 Lower educational attainment was 

associated with HCV in blood donors in Orton et al.104 and Conry-Cantilena et al.106 and in the general 

population in Armstrong et al.30 However, this association was not found in the general population by 

McGinn et al.108 or Nguyen et al.113 An association between HIV and education was not detected in 

general population studies McQuillan et al.101 or Mehta et al.109

GRADE Summary: The association between lower educational level and infection was inconsistent for 

HBV and HCV. For HBV the evidence was also indirect, and so it was rated as very low. For HCV, the 

evidence was rated as very low because there was a dose-response association. For HIV, information was 

consistent but imprecise and therefore rated as very low.

Economic Factors

Being homeless was not associated with an increased risk of HBV among psychiatric inpatient veterans in 

Tabibian et al.121 Ever having been homeless was associated with an increased risk of HCV in adults 

attending general medicine or hepatology clinics in Nguyen et al.113 and being homeless was associated 

with an increased prevalence of HIV in public hospital emergency room patients in Zetola et al.111 Neither 

income or nor living in poverty was associated with HCV in Nguyen et al.113 or Armstrong et al.30 or with 

HIV in McQuillan et al.101

GRADE Summary: Economic factors were inconsistently associated with HCV and HIV, and imprecisely 

associated with HBV and HCV. For all three viruses, the evidence was rated as very low.

Health Insurance

Type of health insurance (Medicaid, Medicare, private, or self-pay) was significantly associated with 

HCV in McGinn et al., a general population study, with Medicaid patients having the highest rates of 
212

HCV.108 Patients with no health insurance had higher prevalence of HIV in one study of hospital patients, 

Mehta et al.,109 but not in another such study, Zetola et al.111

GRADE Summary: The evidence relating health insurance and infection was inconsistent for HCV and 

HIV and imprecise for HIV and therefore rated as very low for both.

Marital Status

Being married may be associated with a lower risk of infection. Being divorced or separated was 

associated with a higher prevalence of HBV in McQuillan et al., a general population study, than any 

other status.29 Being married was associated with a lower rate of HCV among blood donors in Murphy et 

al.105 and a lower prevalence of HIV in the general population in McQuillan et al.101 Marital status was 

not associated with HBV infection among psychiatric inpatient veterans in Butterfield et al.125

GRADE Summary: One study for each HCV and HIV found a relationship between being married and 

having a lower risk of infection and were rated as low. For HBV, infection was higher among divorced or 

single persons in a general population study. A special population study did not find any association 

between marital status and infection, but since it was a special population study we did not detract from 

the GRADE and rated it as low.
213

Evidence Tables for Question 4

Table 39. HBV Nonbehavioral Risk Factors Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Co-Morbidity

Potential Tissue Donors Transfusion

Blood 

transfusion 

recipient or 

donor

Sanchez et 

al.103

2006 Not 

Reported 

(NR)

47 NR 56 NR Not 

significant 

(NS)

Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Nonspecific Exposure

Accidental 

needle stick

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

History of 

transplant

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBVNo Potential tissue donors, 

as reported by next of kin

Surgeries Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

HIV testing Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin
214

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Others

Liver disease Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Treatment by 

physician in 

last 2 years

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Medical 

hospitalizations

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Psychiatric 

hospitalizations

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Medical 

illnesses

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Medications Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Toxic exposure Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Malaria 

exposure or 

treatment

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin
215

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Chagas 

disease 

exposure or 

treatment

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Rabies 

exposure

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Heart disease Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Hypertension Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Kidney disease Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Gastrointestinal 

disease

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Cancer history Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Diabetes 

history

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin
216

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Pulmonary 

disease

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Rheumatologic 

disease

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Connective 

tissue disease

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Dermatologic 

disease

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Neurologic 

disease

Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin

Ocular disease Sanchez et 

al.103

2006 NR 47 NR 56 NR NS Proportion

in HBV+ 

vs. HBV

No Potential tissue donors, 

as reported by next of kin
217

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

General Population Transfusion

Blood 

transfusion

Kaur et al.116 1996 23% 1,432 18.2% 6,107 1.27

(1.04 to 1.57)‡

NR Proportion 

in HBV+ 

vs. HBVYes Volunteers from general 

population

Blood 

transfusion, 

history of, 

household 

contact

Alter et al.117 1989 5% 76 12% 152 NR NS† Proportion 

in HBV+ 

vs. HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Nonspecific Exposure

Needlestick 

injury

Kaur et al.116 1996 15.7% 1,406 19.9% 5,982 0.75

(0.64 to 0.87)†

NR Proportion 

in HBV+ 

vs. HBVNo 

(protective)

Volunteers from general 

population (Note that a 

larger proportion of 

participants than would be 

expected in the general 

population were health 

care workers, and that in 

this population health 

care workers had 

significantly lower HBV 

prevalence)

Hemodialysis Kaur et al.116 1996 37.5% 1,396 18.7% 6,033 2.60

(1.14 to 5.96)†

NR Proportion 

in HBV+ 

vs. HBVYes Volunteers from general 

population

Surgery Kaur et al.116 1996 17.9% 1,446 21.6% 6,147 0.79

(0.70 to 0.89)†

NR Proportion 

in HBV+ 

vs. HBVNo 

(protective)

Volunteers from general 

population
218

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Surgery, 

last six months

Alter et al.117 1989 4% 76 3% 152 NR NS† Proportion 

in HBV+ 

vs. HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Hospitalization, 

last six months

Alter et al.117 1989 13% 76 8% 152 NR NS† Proportion 

in HBV+ 

vs. HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Acupuncture, 

last six months

Alter et al.117 1989 1% 76 0% 152 NR NS† Proportion 

in HBV+ 

vs. HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Medicallyrelated 

injections, 

last six months

Alter et al.117 1989 16% 76 17% 152 NR NS† Proportion 

in HBV+ 

vs. HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Dental work, 

any, 

last six months

Alter et al.117 1989 13% 76 22% 152 NR NS† Proportion 

in HBV+ 

vs. HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Dental work, 

extensive, 

last six months

Alter et al.117 1989 5% 76 6% 152 NR NS† Proportion 

in HBV+ 

vs. HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Other

Vaccinated for 

hepatitis B

Kaur et al.116 1996 7.8% 1,356 22% 8,509 0.40

(0.31 to 0.52)‡

NR Proportion 

in HBV+ 

vs. HBVNo 

(protective)

Volunteers from general 

population
219

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Special Population Exposure to Infected Blood

Needlestick 

injury with 

recognized 

HBV infection

Turner et 

al.127

1989 NR 14 NR 94 NR NR† Prevalence 

HBV+ vs. 

no injury

No Embalmers in highprevalence urban area

Transfusion

Blood 

transfusion 

before 1991

Hwang et 

al.124

2006 4% 269 2.4% 3,999 RR:

1.80

(1.04 to 3.11)† 

<0.05 Prevalence 

HBV+ vs. 

HBVYes College students

Blood 

transfusion

Butterfield et 

al.126

1990 0% 12 2.5% 1,454 1.54

(0.09 to 26.5)†¶

0.77¶ Prevalence 

HBV+ vs. 

HBVNo Obstetric population

Nonspecific Exposure

Organ 

transplantation

Tabibian et 

al.121

2008 0% 40 1% 89 NR NS† Prevalence 

in HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Hemodialysis Hwang et 

al.124

2006 0.7% 270 0.05% 4,045 RR:

7.96

(2.97 to 21.35)†

<0.05 Prevalence 

HBV+ vs. 

HBVYes College students

Acupuncture Tabibian et 

al.121

2008 15% 40 17% 89 NR NS† Prevalence 

in HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Bloody object 

contact

Tabibian et 

al.121

2008 35% 40 20% 89 NR NS† Prevalence 

in HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Combat 

exposure

Butterfield et 

al.125

2004 NR 80 NR 276 1.30

(0.63 to 2.67)‡

NS Prevalence 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans
220

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Household 

contact with 

hepatitis

Hwang et 

al.124

2006 12% 268 7% 3,987 RR:

1.70

(1.19 to 2.42)†

<0.05 Prevalence 

HBV+ vs. 

HBVYes College students

Household 

member with 

hepatitis

Butterfield et 

al.126

1990 0 12 1.3% 1,454 2.96

(0.170 to 

51.78)†¶

0.46¶ Prevalence 

HBV+ vs. 

HBVNo Obstetric population

Wives of men 

surface antigen 

positive

Hann et al.122 2007 6.3 

%HBsAg+, 

57.1% antiHBs+

NR NR NR NR 0.23† Married 

equivalent 

age group 

No Korean-American churchgoers

Family history 

of HBV 

(self-report)

Lin et al.123 2007 NR 283 NR 2,880 RR: 

1.9

(1.4 to 2.6)‡

SS Prevalence 

HBV+ vs. 

no history

Yes Asian Americans

Other infection

Sexually 

transmitted 

disease

Hwang et 

al.124

2006 29% 256 13% 3,924 RR:

2.48

(1.92 to 3.58)†;

OR:

1.61

(1.10 to 2.37)‡

<0.05 Prevalence 

HBV+ vs. 

HBVYes College students

Other

HBV 

Vaccination

Lee et al.120 2008 NR NR NR NR 0.12

(0.05 to 0.29)†

SS Prevalence 

of HBV vs. 

no vaccine

Yes, 

protective

Korean-American churchgoers

HBV 

Vaccination 

(self-report)

Lin et al.123 2007 NR 283 NR 2,880 RR:

0.5

(0.3 to 0.8)‡

SS Prevalence 

HBV+ vs. 

no vaccine

Yes, 

protective

Asian Americans
221

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Demographics

General Population Sex

Male Kaur et al.116 1996 58% 1,416 35% 6,275 2.14

(1.82 to 2.51)‡

SS Proportion 

in HBV+ 

vs. HBVYes Volunteers from general 

population

Age

Age >60 Kaur et al.116 1996 35% 1,356 19% 5,853 1.22

(1.21 to 1.23)‡ 

SS Proportion 

in HBV+ 

vs. HBVin age 

<60 years

Yes Volunteers from general 

population

Race

Race 

White/Hispanic

Kaur et al.116 1996 65% 1,302 84% 5,764 0.32

(0.26 to 0.39)‡

SS Proportion 

in HBV+ 

vs. HBVNo 

(protective)

Volunteers from general 

population

Ethnicity NonHispanic BlackMcQuillan et 

al.29

1999 NR 1,085 NR 20,180 3.9

(2.9 to 5.0)‡

SS Proportion 

in HBV+ 

vs. HBVvs. NonHispanic 

White

Yes General population

Ethnicity 

Mexican 

American

McQuillan et 

al.29

1999 NR 1,085 NR 20,180 0.7

(0.4 to 1.3)‡

NS Proportion 

in HBV+ 

vs. HBVvs. NonHispanic 

White

No General population
222

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Birthplace

Born in 

S.E. Asia or 

Africa

Kaur et al.116 1996 52% 1,421 17.6% 6,069 3.87

(2.81 to 5.34)‡

SS Proportion 

in HBV+ 

vs. HBVYes Volunteers from general 

population

Birth in an area 

with high 

endemic rate of 

HBV, 

household 

contact with 

someone with

Alter et al.117 1989 3% 76 <1% 152 NR NS† Proportion 

in HBV+ 

vs. HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Other than

U.S.

McQuillan et 

al.29

1999 50% 1,236 16.5% 19,971 3.4

(2.0 to 5.8)‡

SS Proportion 

in HBV+ 

vs. HBVYes General population

Occupation

Occupation 

Health Care 

Worker

Kaur et al.116 1996 11.6% 1,453 21.5% 6,185 0.48

(0.41 to 0.56)†

SS Proportion 

in HBV+ 

vs. HBVNo 

(protecti

ve)

Volunteers from general 

population

Medical 

occupation

McQuillan et 

al.29

1999 5% 955 4.7% 15,451 1.07

(0.79 to 1.44)†¶

0.67¶ Proportion 

in HBV+ 

vs. HBVNo General population 

aged at least 17 years

Health care 

employment, 

household 

contact with

Alter et al.117 1989 0% 76 11% 152 NR NS† Proportion 

in HBV+ 

vs. HBVNo General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Military service, 

ever

McQuillan et 

al.29

1999 13.2% 961 14.6% 15,568 0.89

(0.73 to 1.08)‡

0.23 Proportion 

in HBV+ 

vs. HBVNo General population aged 

at least 17 years
223

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Unemployed Alter et al.117 1989 20% 76 6% 152 NR 0.01‡ Proportion 

in HBV+ 

vs. HBVYes General population adults 

with no obvious cause of 

acute HBV and matched 

controls

Education

Education: 

Less than high 

school

McQuillan et 

al.29

1999 56.4% 1,081 40.9% 15,431 1.5

(1.1 to 2.1)‡

SS Proportion 

in HBV+ 

vs. HBV 

vs. some 

college

Yes General population

Education: 

High school

McQuillan et 

al.29

1999 24.3% 1,081 31.0% 15,431 1.1

(0.9 to 1.5)‡

SS Proportion 

in HBV+ 

vs. HBV 

vs. some 

college

No General population

Marital Status

Marital status: 

Divorced/ 

separated

McQuillan et 

al.29

1999 10.6% 1,301 10.7% 15,284 1.6

(1.1 to 2.2)‡

SS Proportion 

in HBV+ 

vs. HBV 

vs. any 

other 

status

Yes General population aged 

at least 17 years
224

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Children and Adolescents Birthplace

Korean-born 

children: 

Carrier rate

Hann et al.122 2007 NR NR NR NR NR 0.022† U.S. born Yes Korean-American churchgoers, children

Korean-born 

children: 

antibody rate

Hann et al.122 2007 NR NR NR NR NR <0.001† U.S. born Yes Korean-American churchgoers, children

Special Populations Sex

Male Tabibian et 

al.121

2008 100% 40 96.6% 89 NR NS† Prevalence in 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Male Hwang et 

al.124

2006 32% 274 39% 4,047 RR:

0.77

(0.61 to 0.99)†;

OR:

0.69

(0.49 to 0.97)‡

<0.05 for 

both

Prevalence 

HBV+ vs. 

HBVNo, 

protecti

ve

College students

Male Lin et al.123 2007 NR NR NR NR RR:

2.1

(1.6 to 2.7)‡

SS Prevalence 

HBV+ in 

Females 

Yes Asian Americans

Male Lee et al.120 2008 NR 24 NR 609 1.69

(0.96 to 2.98)†

NS Prevalence 

HBV+ vs. 

HBVNo Korean Americans
225

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Age

Age, mean Tabibian et 

al.121

2008 48.9 mean 40 48.9 

mean

89 NR NS† Mean age 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Age 

(continuous)

Hwang et 

al.124

2006 NR 269 NR 4,054 1.04

(1.03 to 1.06)‡

<0.05 Mean age 

in HBV+ 

vs. HBVYes College students

Age ≤20 years Hann et al.122 2007 NR 377 NR 5,753 NR 0.0051† >20 years Yes Korean-American churchgoers

Age ≤30 years Lee et al.120 2008 NR NR NR NR 0.072

(0.02 to 0.21)

SS HBV+ vs. 

HBV- in 

age 

>50 years

Yes, 

protecti

ve

Korean-American churchgoers

Age 30 to 

49 years

Lee et al.120 2008 NR NR NR NR 0.287

(0.15 to 0.55)†

<0.001 HBV+ vs. 

HBV- in 

age 

>50 years

Yes, 

protecti

ve

Korean-American churchgoers

Age over 

35 years

Turner et 

al.127

1989 NR 14 NR 94 RR:

3.6

(1.2 to 11.2)†

NR HBV+ in 

<35 years

Yes Embalmers in highprevalence urban area

Age over 

50 years

Butterfield et 

al.125

2004 NR 80 NR 276 1.27

(0.67 to 2.39)‡

NS Prevalence 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Age 30-39 Lin et al.123 2007 NR 283 NR 2,880 RR:

1.4

(0.7 to 2.6)‡

NS Prevalence 

HBV+ in 

age <30

No Asian Americans
226

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size*p-Value**

Comparison MadeAssociated in Study?

Population

Age 40-49 Lin et al.123 2007 NR 283 NR2,880 RR

:

1.5

(0.9 to 2.7)‡

NS Preva

-

lence 

HBV+ in 

age <30

No Asian Americans

Age 50-59 Lin et al.123 2007 NR 283 NR2,880 RR

:

1.0

(0.6 to 1.5)‡

NS Preva

-

lence 

HBV+ in 

age <30

No Asian Americans

Age 60-69 Lin et al.123 2007 NR 283 NR2,880 RR

:

0.9

(0.5 to 1.7)‡

NS Preva

-

lence 

HBV+ in 

age <30

No Asian Americans

Age ≥70 Lin et al.123 2007 NR 283 NR2,880 RR

:

0.6

(0.3 to 1.2)‡

NS Preva

-

lence 

HBV+ in 

age <30

No Asian Americans

Race/Ethnicity

Ethnicity, 

Caucasian

Tabibian et 

al.121

2008 40% 40 55% 89 NR NS† Preva

-

lence in 

HBV+ vs. 

HBV-

No Psychiatric inpatient 

veterans

Ethnicity, 

African-

American

Tabibian et 

al.121

2008 37.5% 40 31% 89 NR NS† Preva

-

lence in 

HBV+ vs. 

HBV-

No Psychiatric inpatient 

veterans
227

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

AfricanAmerican RaceButterfield et 

al.125

2004 NR 80 NR 276 2.79

(1.41 to 5.53)‡

<0.01 Prevalence 

HBV+ vs. 

HBV- vs. 

White

Yes Psychiatric inpatient 

veterans

Black nonHispanicHwang et 

al.124

2006 36% 269 26% 4,001 RR:

1.92

(1.44 to 2.56)†;

OR:

1.95

(1.34 to 2.84)‡

<0.05 for 

both

Prevalence 

HBV+ vs. 

HBV- vs. 

White 

nonHispanic

Yes College students

Ethnicity, 

Hispanic

Tabibian et 

al.121

2008 12.5% 40 8% 89 NR NS† Prevalence in 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Hispanic or 

Latino

Hwang et 

al.124

2006 12% 269 23% 4,001 RR:

0.72

(0.48 to 1.08)†;

OR:

0.81

(0.49 to 1.34)‡

NS Prevalence 

HBV+ vs. 

HBV- vs. 

White 

nonHispanic

No College students
228

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Asian Hwang et 

al.124

2006 20% 269 5% 4,001 RR:

4.49

(3.26 to 6.19)†;

OR:

9.98

(6.01 to 16.55)‡

<0.05 for 

both

Prevalence 

HBV+ vs. 

HBV- vs. 

White 

nonHispanic

Yes College students

Birth-country

Country of 

birth: 

East Asia, 

excluding 

China

Lin et al.123 2007 NR 283 NR 2,880 RR:

0.8

(0.6 to 1.1)‡

NS Prevalence 

HBV+ vs. 

born in 

China

No Asian Americans

Country of 

birth: 

Southeast 

Asia/Pacific 

Islands

Lin et al.123 2007 NR 283 NR 2,880 RR:

1.2

(0.8 to 1.7)‡

NS Prevalence 

HBV+ vs. 

born in 

China

No Asian Americans

Country of 

birth: 

United States

Lin et al.123 2007 NR 283 NR 2,880 RR:

0.05

(0.01 to 0.3)‡

SS Prevalence 

HBV+ vs. 

born in 

China

Yes, 

protective

Asian Americans
229

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Occupation

Health care 

workers

Tabibian et 

al.121

2008 17.5% 40 12.0% 89 NR NS† Prevalence in 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Healthcarerelated job with 

frequent blood 

exposure

Hwang et 

al.124

2006 7% 270 4% 3,987 RR:

1.83

(1.18 to 2.84)†

<0.05 HBV- Yes College students

Healthcare 

worker or 

spouse of

Butterfield et 

al.126

1990 8% 12 7.5% 1,454 1.07

(0.13 to 8.7)†¶

0.947¶ Prevalence 

HBV+ vs. 

HBVNo Obstetric population

Education

Education, 

years

Tabibian et 

al.121

2008 13.5 mean 40 13.4 

mean

129 NR NS† Mean 

years 

education 

in HBV+ 

vs. HBVNo Psychiatric inpatient 

veterans

Enrolled in 

2 year college

Hwang et 

al.124

2006 48% 274 33% 4,054 RR:

1.81

(1.44 to 2.27)†;

OR:

1.64

(1.13 to 2.40)‡

p <0.05 HBV 

prevalence vs. 

4 year 

college

Yes College students
230

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison MadeAssociated in Study?

Population

Economic

Homeless Tabibian et 

al.121

2008 77.5% 40 66% 89 NR NS† Prevalence in 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Independent or 

live with family 

(vs. homeless, 

institutionalized, or other)

Butterfield et 

al.125

2004 NR 80 NR 276 0.82

(0.39 to 1.72)‡

NS Prevalence 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

Marital 

Status

Currently 

married

Butterfield et 

al.125

2004 NR 80 NR 276 1.67

(0.83 to 3.40)‡

NS Prevalence 

HBV+ vs. 

HBVNo Psychiatric inpatient 

veterans

* Odds ratios as reported in publication, unless otherwise specified

** As reported in publication, unless otherwise specified

† Univariate, unadjusted

‡ Multivariate, adjusted for other factors

¶ Calculated by ECRI Institute
231

Table 40. HCV: Nonbehavioral Risk Factors Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Signs and Symptoms 

Blood Donors Signs

ALT reactive Orton et al.104 2004 20% 65 <1% 225 47

(6.7 to 2,004)†

<0.001 Proportion in 

HCV+ vs. 

HCVYes Blood donors

General Population Signs

Jaundice Nguyen et 

al.113

2005 20.3% 225 5.4% 204 Not reported 

(NR)

<0.001 Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Serum alanine 

aminotransferase 

levels <40 U/L

Armstrong et

al.30

2006 49% 220 92% 12,900 NR Not 

significant

(NS)†

0-39 U/L No General 

population 

aged 18 to 

49 years

Serum alanine 

aminotransferase 

levels 40-79 U/L

Armstrong et 

al.30

2006 35% 220 7% 12,900 NR <0.005† 0-39 U/L Yes General 

population 

aged 18 to 

49 years

Serum alanine 

aminotransferase 

levels 80-119 U/L

Armstrong et 

al.30

2006 7% 220 1% 12,900 NR >0.05† 0-39 U/L Yes General 

population 

aged 18 to 

49 years
232

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Serum alanine 

aminotransferase 

levels ≥120 U/L

Armstrong et 

al.30

2006 8% 220 4% 12,900 NR >0.05† 0-39 U/L Yes General 

population 

aged 18 to 

49 years

Elevated liver 

enzyme

Fischer et 

al.114

2000 27% 11 6% 1,369 NR <0.05† Proportion in 

HCV+ vs. 

HCVYes Adults comprising 

individuals at risk 

for HCV and 

healthcareworker

s enrolled in 

HMO

Hepatitis-related 

diagnoses (HAV, 

HBV, HIV, or 

elevated liver 

enzyme from 

health record)

Fischer et 

al.114

2000 NR 11 NR 1,369 13.9

(2.7 to 72.1)†

0.002 Proportion in 

HCV+ vs. 

HCVYes Adults comprising 

individuals at risk 

for HCV and 

healthcareworker

s enrolled in 

HMO

Co-Morbidity

Potential Tissue Donors Transfusion

Blood transfusion 

recipient or donor

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS Proportion in 

HCV+ vs. 

HCVNo Potential tissue 

donors, as 

reported by 

next of kin
233

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size*p-Value**

Comparison made Associated in Study?

Population

Nonspecific Exposure

History of transplant Sanchez et 

al.103

2006 NR 18 NR 56 NR NS Proportion in 

HCV+ vs. 

HCV

No Potential tissue donors, 

as reported by 

next of kin

Accidental needle 

stick

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS Proportion in 

HCV+ vs. HCV

No Potential tissue 

donors, 

as reported by 

next of kin

Surgeries Sanchez et 

al.103

2006 NR 18 NR 56 NR NS Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, 

as reported by 

next of kin

HIV testing Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† 

Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, 

as reported by 

next of kin

Other

Liver disease Sanchez et 

al.103

2006NR 18 NR 56 NR NS Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, 

as reported by 

next of kin

Chest pain Sanchez et 

al.103

2006 NR 18 NR 56 2.66

(0.96 to 7.38)†

0.054 Proportion in 

HCV+ vs. 

HCV

Yes Potential tissue 

donors, 

as reported by 

next of kin
234

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Cardiac medications Sanchez et 

al.103

2006 NR 18 NR 56 2.84

(1.0 to 8.07)†

0.043 Proportion in 

HCV+ vs. 

HCV

Yes Potential tissue 

donors, 

as reported by 

next of kin

Kidney stones Sanchez et 

al.103

2006 NR 18 NR 56 5.48

(1.38 to 21.80)†

0.008 Proportion in 

HCV+ vs. 

HCV

Yes Potential tissue 

donors, as 

reported by next

of kin

Lung disease Sanchez et 

al.103

2006 NR 18 NR 56 3.20

(0.98 to 10.41)†

0.044 Proportion in 

HCV+ vs. 

HCV

Yes Potential tissue 

donors, as 

reported by next

of kin

Treatment by 

physician in 

last 2 years

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by next

of kin

Medical 

hospitalizations

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by next

of kin

Psychiatric 

hospitalizations

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by next

of kin
235

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Medical illnesses Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by next

of kin

Medications Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Toxic exposure Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Malaria exposure or 

treatment

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Chagas disease 

exposure or 

treatment

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Rabies exposure Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin
236

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Heart disease Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Hypertension Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Kidney disease Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Gastrointestinal 

disease

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Cancer history Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Diabetes history Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin
237

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Pulmonary disease Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Rheumatologic 

disease

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Connective tissue 

disease

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Dermatologic 

disease

Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Neurologic disease Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin

Ocular disease Sanchez et 

al.103

2006 NR 18 NR 56 NR NS† Proportion in 

HCV+ vs. 

HCV

No Potential tissue 

donors, as 

reported by 

next of kin
238

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Potential and Actual Organ Donors Infection

HBV Surface 

Antigen Positive

Gasink et al.102 2006 0.4% 261 0.03% 10,654 NR 0.003† Proportion in 

HCV+ vs. 

HCVYes Heart transplant 

donors

Other

Diabetes mellitus Gasink et al.102 2006 1.6% 261 1.7% 10,654 NR 0.86† Proportion in 

HCV+ vs. 

HCV

No Heart transplant 

donors

Previous myocardial 

infarction

Gasink et al.102 2006 0 261 0.68% 10,654 NR 0.18† Proportion in 

HCV+ vs. 

HCV

No Heart transplant 

donors

Hypertension Gasink et al.102 2006 15.2% 261 11.3% 10,654 NR 0.05† Proportion in 

HCV+ vs. 

HCV

Yes Heart transplant 

donors

Creatinine 

>1.5 mg/dL

Gasink et al.102 2006 12.3% 261 13.4% 10,654 NR 0.60† Proportion in 

HCV+ vs. 

HCV

No Heart transplant 

donors
239

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Blood Donors Transfusion

Transfusion ConryCantilena et 

al.106

1996 27% 248 8% 131 4.68

(3.44 to 6.36)†¶

<0.001‡ Proportion in 

HCV+ vs. 

HCVYes Blood donors 

initially positive 

on enzyme-linked 

immunosorbent 

assay (EIA)

Received blood 

transfusion

Murphy et 

al.105

2000 23% 758 6% 1,039 Non-IDU:

10.9

(6.5 to 18.2)†;

IDU:

0.9

(0.1 to 9.1)†

Statistically significant (SS)

for nonIDU, NS 

for IDU

Proportion in 

HCV+ vs. 

HCV- final 

multivariable 

logistic 

regression 

model

Yes, 

for 

nonIDU

Blood donors

Previous blood 

transfusion

Murphy et 

al.107

1996 13% 3,126 5.9% 859,272 2.8

(2.5 to 3.1)‡

SS Proportion in 

HCV+ vs. 

HCVYes Blood donors

Nonspecific Exposure

Needle stick among 

healthcare workers

ConryCantilena et 

al.106

1996 4% 248 2% 131 NR >0.05† Proportion in 

HCV+ vs. 

HCVNo Blood donors 

initially positive 

on EIA

Bloody needle stick 

injury in medical 

context

Murphy et 

al.105

2000 11% 758 4% 1,039 3.2

(1.9 to 2.6)‡

SS Proportion in 

HCV+ vs. 

HCVadjusted for 

IDU

Yes Blood donors
240

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Stuck/cut with 

bloody object

Murphy et 

al.105

2000 11% 758 4% 1,039 2.1

(1.1 to 4.1)‡

SS Proportion in 

HCV+ vs. 

HCV-final 

multivariable 

logistic 

regression 

model

Yes Blood donors

Had same-day 

surgery in the 

6 months 

before donation

Orton et al.104 2004 9.2% 65 6.3% 225 1.5

(0.5 to 4.5)†

0.41 Proportion in 

HCV+ vs. 

HCVNo Blood donors

Had a medical 

and/or surgical 

procedure in the 

6 months 

before donation

Orton et al.104 2004 21.5% 65 14.3% 225 1.6

(0.8 to 3.3)†

0.16 Proportion in 

HCV+ vs. 

HCVNo Blood donors

Had surgery Murphy et 

al.105

2000 74% 758 64% 1,039 1.7

(1.2 to 2.4)‡

SS Proportion in 

HCV+ vs. 

HCVadjusted for 

IDU

Yes Blood donors

Had sutures Murphy et 

al.105

2000 77% 758 65% 1,039 1.7

(1.2 to 2.4)‡

SS Proportion in 

HCV+ vs. 

HCVadjusted for 

IDU

Yes Blood donors
241

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Was hospitalized in 

the 6 months 

before donation

Orton et al.104 2004 7.7% 65 2.2% 225 3.7

(0.8 to 16)†

0.05 Proportion in 

HCV+ vs. 

HCVYes Blood donors

Acupuncture 

treatment

ConryCantilena et 

al.106

1996 4% 248 1% 131 NR >0.05† Proportion in 

HCV+ vs. 

HCVNo Blood donors 

initially positive 

on EIA

Acupuncture Murphy et 

al.105

2000 9% 758 5% 1,039 1.4

(0.8 to 2.4)‡

NS Proportion in 

HCV+ vs. 

HCVadjusted for 

IDU

No Blood donors

Had dental work in 

the 6 months 

before donation

Orton et al.104 2004 35.4% 65 38.8% 225 0.9

(0.5 to 1.5)† 

0.61 Proportion in 

HCV+ vs. 

HCVNo Blood donors

Teeth cleaned 

1-10 times

Murphy et 

al.105

2000 57% 758 46% 1,039 0.7

(0.3 to 1.4)‡

NS Proportion in 

HCV+ vs. 

HCVadjusted for 

IDU with 

reference to 

never had 

cleaning

No Blood donors
242

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size*p-Value**

Comparison made Associated in Study?

Population

Teeth cleaned 

11-20 times

Murphy et 

al.105

2000 23% 758 33% 1,039 0.5

(0.2 to 1.0)‡

NS Proportion in 

HCV+ vs. 

HCV-

adjusted for 

IDU with 

reference to 

never had 

cleaning

No Blood donors

Teeth cleaned 

>20 times

Murphy et 

al.105

2000 11% 758 12% 1,039 0.6

(0.2 to 1.3)‡

NS Proportion in 

HCV+ vs. 

HCV-

adjusted for 

IDU with 

reference to 

never had 

cleaning

No Blood donors

Tooth extraction Murphy et 

al.105

2000 73% 758 68% 1,039 1.3

(0.9 to 1.8)‡

NS Proportion in 

HCV+ vs. 

HCV-

adjusted for 

IDU 

No Blood donors

In a fight with 

blood exposure 

last6 months

Orton et al.104 2004 7.7% 65 2.2% 225 3.7

(0.8 to 16†

0.05 Proportion in 

HCV+ vs. 

HCV-

Yes Blood donors

By a bite with 

blood exposure 

last6 months

Orton et al.104 2004 4.6% 65

0% 225 Undefined 

(because zero 

in uninfected 

group)

0.01 Proportion in 

HCV+ vs. 

HCV-

Yes Blood donors
243

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

During a haircut 

with blood exposure 

last 6 months

Orton et al.104 2004 23.1% 65 13.8% 225 1.9 (0.9 to 3.9)† 0.11 Proportion in 

HCV+ vs. 

HCVNo Blood donors

During a manicure 

with blood exposure 

last 6 months 

(women only)

Orton et al.104 2004 20.0% 30 3.8% 105 5.2

(1.1 to 27) †

0.02 Proportion in 

HCV+ vs. 

HCVYes Blood donors

At accident site with 

blood exposure 

last 6 months

Orton et al.104 2004 6.2% 65 1.3% 225 4.9

(0.8 to 34) †

0.05 Proportion in 

HCV+ vs. 

HCVYes Blood donors

Lived with hepatitis 

case

Murphy et 

al.105

2000 16% 758 6% 1,039 1.4

(0.9 to 1.5)‡

NS Proportion in 

HCV+ vs. 

HCVadjusted for 

IDU

No Blood donors

Relative with 

hepatitis

Murphy et 

al.105

2000 12% 758 8% 1,039 0.9

(0.6 to 1.5)‡

NS Proportion in 

HCV+ vs. 

HCVadjusted for 

IDU

No Blood donors

Lived with 

transfusion recipient

Murphy et 

al.105

2000 12% 758 7% 1,039 1.5

(1.0 to 2.3)‡

SS Proportion in 

HCV+ vs. 

HCVadjusted for 

IDU

Yes Blood donors
244

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Other infection

Had a sexually 

transmitted disease 

(STD) in 

last 6 months 

before donation

Orton et al.104 2004 6.2% 65 0% 225 Undefined 

(because zero 

in control group 

had factor)

0.002† Proportion in 

HCV+ vs. 

HCVYes Blood donors

History of STD ConryCantilena et 

al.106

1996 28% 248 10% 131 NR <0.001† Proportion in 

HCV+ vs. 

HCVYes Blood donors 

initially positive 

on EIA

STD Murphy et 

al.105

2000 33% 758 15% 1,039 2.5

(1.8 to 3.5)‡

SS Proportion in 

HCV+ vs. 

HCVadjusted for 

IDU

Yes Blood donors

Other reactive 

infections disease 

markers (HIV, 

syphilis)

Orton et al.104 2004 8% 65 0% 225 Undefined 

(because zero 

in control 

group)

<0.001† Proportion in 

HCV+ vs. 

HCVYes Blood donors

Seropositive for 

other infectious 

diseases (HTLV I 

and II, HIV, HBVcore)

Murphy et 

al.107

1996 NR 3,126 NR 859,272 10.4

(9.6 to 11.4)‡

SS Proportion in 

HCV+ vs. 

HCVYes Blood donors
245

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Other

Received 

Hepatitis B Vaccine 

in last 6 months

Orton et al.104 2004 32.3% 65 24.6% 225 1.5

(0.8 to 2.7)†

0.21 Proportion in 

HCV+ vs. 

HCVNo Blood donors

Gamma globulin 

injection

Murphy et 

al.105

2000 22% 758 16% 1,039 1.6

(1.0 to 2.6)‡

SS Proportion in 

HCV+ vs. 

HCV-final 

multivariable 

logistic 

regression 

model

Yes Blood donors

History of hepatitis Orton et al.104 2004 1.5% 65 1.8% 225 0.9

(0.02 to 10) †

1.00 Proportion in 

HCV+ vs. 

HCVNo Blood donors

History of liver 

disease

ConryCantilena et 

al.106

1996 31% 248 5% 131 NR <0.001† Proportion in 

HCV+ vs. 

HCVYes Blood donors 

initially positive 

on EIA
246

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

General Population Transfusion

Blood transfusion Nguyen et 

al.113

2005 43.2% 225 13.7% 204 8.62

(4.71 to 15.80)† 

<0.001 HCV- Yes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Blood transfusion(s) Hand and 

Vasquez112

2005 25% 320 19% 307 NR†; 

3.2

(2.0 to 5.1)‡

0.051†;

<0.001‡

Proportion in 

HCV+ vs. 

HCVYes Adults tested for 

HCV in health 

system because 

of clinical 

suspicion

Blood transfusion Kaur et al.116 1996 14.6% 559 7.1% 6,170 4.09

(2.97 to 5.62)‡

NR Proportion in 

HCV+ vs. 

HCVYes Volunteers from 

general 

population

Transfusion, blood, 

before 1992

Armstrong et 

al.30

2006 14% 128 5% 5,665 2.6

(0.9 to 7.3)‡

<0.005 Proportion in 

HCV+ vs. 

HCVYes General 

population 

aged 20 to 59 

years

Transfusion, blood, 

before 1992, 

self-reported

Fischer et 

al.114

2000 55% 11 25% 1,369 4.61

(3.42 to 6.21)†¶

<0.001 Proportion in 

HCV+ vs. 

HCVYes Adults comprising 

individuals at risk 

for HCV and 

healthcareworker

s enrolled in 

HMO
247

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size*p-Value**

Comparison made Associated in Study?

Population

Transfusion, blood, 

before 1992, 

as recognized in 

HMO database

Fischer et 

al.114

20000% 11 <1%1,369 NR NS† Proportion in 

HCV+ vs. 

HCV-

No Adults comprising 

individuals at risk 

for HCV and 

healthcareworker

s enrolled in 

HMO

Nonspecific Exposure

Needlestick injury Kaur et al.116 1996 6.4% 543 8.9%5,982 0.70

(0.55 to 0.89)†

NR Proportion in 

HCV+ vs. 

HCV-

No 

(protective)

Volunteers from 

general 

population – Note 

this population 

had a large

proportion of 

healthcare 

workers who had 

a lower infection 

prevalence 

Contact with blood Hand and 

Vasquez11

2

20055% 3204% 307 NR 0.798† Proportion in 

HCV+ vs. 

HCV-

No Adults tested for 

HCV in health 

system because 

of clinical 

suspicion

Surgery, any Fischer et 

al.114

2000 91% 11 78%1,369 NR NS† Proportion in 

HCV+ vs. 

HCV-

No Adults comprising 

individuals at risk 

for HCV and 

healthcareworker s enrolled in 

HMO
248

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Surgery Kaur et al.116 1996 8.3% 565 8.6% 6,147 0.96

(0.80 to 1.16)†

NS Proportion in 

HCV+ vs. 

HCVNo Volunteers from 

general 

population

Surgery, exploratory Fischer et 

al.114

2000 55% 11 41% 1,369 NR NS† Proportion in 

HCV+ vs. 

HCVNo Adults comprising 

individuals at risk 

for HCV and 

healthcareworker

s enrolled in 

HMO

Emergency 

department 

treatment

Nguyen et 

al.113

2005 88.3% 225 79.4% 204 NR 0.02† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Hospitalization Nguyen et 

al.113

2005 87.8% 225 76.5% 204 NR 0.003† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Kidney dialysis Nguyen et 

al.113

2005 5.4% 225 0.5% 204 11.36

(1.15 to 86.5)†¶

0.003† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)
249

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Hemodialysis Hand and 

Vasquez112

2005 1% 320 3% 307 NR 0.068† Proportion in 

HCV+ vs. 

HCVNo Adults tested for 

HCV in health 

system because 

of clinical 

suspicion

Hemodialysis Kaur et al.116 1996 42.3% 544 8.1% 6,033 10.95

(3.85 to 31.13)‡

NR Proportion in 

HCV+ vs. 

HCVYes Volunteers from 

general 

population

Acupuncture Hand and 

Vasquez112

2005 2% 320 0.7% 307 NR 0.106† Proportion in 

HCV+ vs. 

HCVNo Adults tested for 

HCV in health 

system because 

of clinical 

suspicion

Family member 

treated for viral 

hepatitis

Fischer et 

al.114

2000 9% 11 6% 1,369 NR NS† Proportion in 

HCV+ vs. 

HCVNo Adults comprising 

individuals at risk 

for HCV and 

healthcareworker

s enrolled in 

HMO

At least one family 

member with HCV

Nguyen et 

al.113

2005 21.2% 225 6.9% 204 NR <0.001† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)
250

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Had a blood test for 

HBV

Nguyen et 

al.113

2005 78.8% 225 24.5% 204 NR <0.001† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Other 

Infection

HIV positive Nguyen et 

al.113

2005 1.8% 225 1.5% 204 NR >0.99† Proportion 

HCV+ vs. 

HCVNo Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

HIV positive Armstrong et 

al.30

2006 3% 134 0.5% 5,549 NR Inconclusive 

due to 

small 

number 

positives

HCV- Incon

clusive

Adults in general 

population aged 

18 to 49 years

HIV positive Hand and 

Vasquez112

2005 10% 320 8% 307 NR 0.351† Proportion in 

HCV+ vs. 

HCVNo Adults tested for 

HCV in health 

system because 

of clinical 

suspicion

HBV Positive, 

self-report

Nguyen et 

al.113

2005 21.2% 225 2.5% 204 4.71

(1.49 to 14.83)† 

NR Proportion

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)
251

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Herpes Simplex 

Virus Type 2 

(HSV-2) Positive

Armstrong et 

al.30

2006 43% 134 19% 5,476 NR <0.005† Proportion 

HCV+ vs. 

HCVYes General 

population age 

18 to 49 years

STD, past treatment 

for

Nguyen et 

al.113

2005 24.8% 225 18.1% 204 NR 0.10† Proportion 

HCV+ vs. 

HCVNo Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Other

Blood donor Nguyen et 

al.113

2005 38.7% 225 58.3% 204 NR <0.001† Proportion 

HCV+ vs. 

HCVNo 

(prot

ectiv

e)

Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Blood donor, 

rejected as

Nguyen et 

al.113

2005 28.4% 225 16.2% 204 2.57

(1.49 to 4.43)†

0.002 Proportion 

HCV+ vs. 

HCV

Yes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Vaccinated for 

hepatitis B

Kaur et al.116 1996 2.8% 528 10% 5,737 0.37

(0.22 to 0.62)‡

NR Proportion in 

HCV+ vs. 

HCVNo 

(prot

ectiv

e)

Volunteers from 

general 

population
252

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Refused life 

insurance

Nguyen et 

al.113

2005 20.7% 225 3.9% 204 2.75

(1.05 to 7.25)† 

<0.001 Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Hepatitis diagnosis Fischer et 

al.114

2000 36% 11 4% 1,369 NR <0.001† Proportion in 

HCV+ vs. 

HCVYes Adults comprising 

individuals at risk 

for HCV and 

healthcareworker

s enrolled in 

HMO

Moving motor 

vehicle accident

Nguyen et 

al.113

2005 15.3% 225 5.4% 204 NR <0.001† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Diabetes mellitus Nguyen et 

al.113

2005 14.4% 225 9.8% 204 NR 0.18† Proportion 

HCV+ vs. 

HCVNo Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Heart disease Nguyen et 

al.113

2005 5.4% 225 6.9% 204 NR 0.55† Proportion 

HCV+ vs. 

HCVNo Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)
253

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

“Blood problems” Nguyen et 

al.113

2005 18.5% 225 5.4% 204 NR <0.001† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Treated for chronic 

fatigue

Fischer et 

al.114

2000 18% 11 10% 1,369 NR NS† Proportion in 

HCV+ vs. 

HCVNo Adults comprising 

individuals at risk 

for HCV and 

healthcareworker

s enrolled in 

HMO

Injection of 

medication in 

Mexico

Hand and 

Vasquez112

2005 22% 320 27% 307 NR 0.164† Proportion in 

HCV+ vs. 

HCVNo Adults tested for 

HCV in health 

system because 

of clinical 

suspicion

Demographics

Potential Organ Donors Sex

Male Sex Gasink et al.102 2006 80.1% 261 31% 10,654 NR <0.001 HCV- Yes Heart transplant 

donors

Age

Age, median and 

interquartile range

Gasink et al.102 2006 Median: 

38 

(IQR: 

32-43) 

261 Median: 

29

(IQR: 

20-41)

10,654 NR <0.001 HCV- Yes Heart transplant 

donors
254

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Race/Ethnicity

Ethnicity: White Gasink et al.102 2006 87.7% 261 85.5% 10,654 NR 0.55 Proportions in 

HCV+ vs. 

HCVNo Heart transplant 

donors

Ethnicity: Black Gasink et al.102 2006 10.7% 261 12.3% 1,304 NR

Ethnicity: Other Gasink et al.102 2006 1.5% 261 2.2% 10,654 NR

Blood Donors Sex

Male Sex Orton et al.104 2004 54% 65 54% 225 1.0

(0.6 to 1.8)†

0.97 Proportion in 

HCV+ vs. 

HCVNo Blood donors

Male Sex Murphy et 

al.107

1996 66% 3,126 53% 859,272 1.9

(1.8 to 2.1)‡ 

SS Proportion in 

HCV+ vs. 

HCVYes Blood donors

Female sex ConryCantilena et 

al.106

1996 44% 248 37% 131 NR 0.17† Proportion in 

HCV+ vs. 

HCVNo Blood donors 

initially positive 

on EIA

Age

Mean age Orton et al.104 2004 43 

(mean 

age)

65 41

(mean 

age)

225 NR <0.001 Mean in 

HCV+ vs. 

HCVNo Blood donors

Mean age ConryCantilena et 

al.106

1996 37 

(mean 

age)

248 44

(mean 

age)

131 NR <0.001† Proportion in 

HCV+ vs. 

HCVYes Blood donors 

initially positive 

on EIA
255

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Race/Ethnicity

White non-Hispanic Orton et al.104 2004 84% 65 89% 225 1.6

(0.7 to 3.5)†

0.26 HCV+ race 

“other”

No Blood donors

Black race ConryCantilena et 

al.106

1996 19% 248 7% 131 NR 0.002† Proportion in 

HCV+ vs. 

HCVYes Blood donors 

initially positive 

on EIA

Black race Murphy et 

al.107

1996 17% 3,126 7% 859,272 1.7

(1.6 to 1.9)‡

SS Proportion in 

HCV+ vs. 

HCV- with 

reference to 

white

Yes Blood donors

Asian Murphy et 

al.107

1996 1.8% 3,126 3% 859,272 0.4

(0.3 to 0.6)‡

SS Proportion in 

HCV+ vs. 

HCV- with 

reference to 

white

No 

(prot

ectiv

e)

Blood donors

Hispanic Orton et al.104 2004 5% 65 7% 225 0.6

(0.1 to 2.1)†

0.58 Proportion in 

HCV+ vs. 

HCVNo Blood donors

Hispanic Murphy et 

al.107

1996 8.4% 3,126 6% 859,272 1.3

(1.1 to 1.5)‡

SS Proportion in 

HCV+ vs. 

HCV- with 

reference to 

white

Yes Blood donors

Birthpla

ce

Foreign (not U.S.) Orton et al.104 2004 1.5% 65 7.6% 225 0.2

(0.0 to 1.3)†

0.09 Proportion in 

HCV+ vs. 

HCVNo Blood donors
256

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Foreign (not U.S.) Murphy et 

al.107

1996 6% 3,126 6% 859,272 2.8

(2.5 to 3.1)‡

SS Proportion in 

HCV+ vs. 

HCVYes Blood donors

Occupation

Occupational blood 

exposure

Murphy et 

al.105

2000 24% 758 17% 1,039 1.7

(1.2 to 2.3)‡

SS Proportion

HCV+ vs. 

HCVYes Blood donors

Medical or dental 

job (frequent blood 

contact)

Orton et al.104 2004 9.2% 65 3.6% 225 2.8

(0.8 to 9.4)†

0.09 Proportion in 

HCV+ vs. 

HCVNo Blood donors

Public safety job 

(frequent blood 

contact)

Orton et al.104 2004 3.1% 65 3.6% 225 1.0

(0.1 to 5.4)†

1.00 Proportion in 

HCV+ vs. 

HCVNo Blood donors

Education

High School/

GED or less

Orton et al.104 2004 48% 65 28% 225 4.76 

(confidence 

intervals 

not reported)

<0.001 Test for trend 

among the 

three 

educational 

strata

Yes 

– low 

level

Blood donor

Associate/ 

vocational-technical

Orton et al.104 2004 40% 65 40% 225 2.8

At least Bachelor’s 

degree

Orton et al.104 2004 12% 65 32% 225 1.0 

No college 

education

ConryCantilena et 

al.106

1996 54% 248 16% 131 NR <0.001 Proportion in 

HCV+ vs. 

HCVYes Blood donors 

initially positive 

on EIA
257

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Marital 

Status

Married Murphy et 

al.105

2000 60% 758 71% 1,039 0.61

(0.50 to 0.75)†¶

<0.001 Proportion in 

HCV+ vs. 

HCVYes, 

protective

Blood donors

General Population Sex

Male Nguyen et 

al.113

2005 55.0% 225 28.1% 204 NR <0.001† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Male McGinn et 

al.108

2009 40% 83 25% 917 NR 0.02† Proportion in 

HCV+ vs. 

HCVYes In adult primary 

care clinic

Male Armstrong et 

al.30

2006 64% 238 48% 14,841 NR <0.05† Proportion 

with HCV+ 

vs. HCVYes General 

population

Male Fischer et

al.114

2000 36% 11 43% 1,369 NR NS † Proportion 

with HCV+ 

vs. HCVNo Adults comprising 

individuals at risk 

for HCV and 

healthcareworker

s enrolled in 

HMO

Male Kaur et al.116 1996 13.4% 544 4.7% 6,275 3.60

(2.66 to 4.87)‡

NR Proportion in 

HCV+ vs. 

HCVYes Volunteers from 

general 

population
258

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Age

Age, mean and 

standard deviation

McGinn et 

al.108

2009 Mean:

52.9

(SD:

9.7)

83 Mean: 

49.8

(SD:

14.7)

917 NR 0.01† Mean in 

HCV+ vs. 

HCVYes In adult primary 

care clinic

Age, decade of Birth

1910-1919

Nguyen et 

al.113

2005 0% 225 0.5% 204 NR <0.001† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases) Age, decade of Birth

1920-1929

Nguyen et 

al.113

2005 0.9% 225 5.4% 204

Age, decade of Birth

1930-1939

Nguyen et 

al.113

2005 7.7% 225 7.8% 204

Age, decade of Birth

1940-1949

Nguyen et 

al.113

2005 24.9% 225 14.7% 204

Age, decade of Birth

1950-1959

Nguyen et 

al.113

2005 51.4% 225 22.5% 204

Age, decade of Birth

1960-1969

Nguyen et 

al.113

2005 13.1% 225 24.0% 204

Age, decade of Birth

1970-1979

Nguyen et

al.113

2005 2.3% 225 22.5% 204

Age, decade of Birth

1980-1989

Nguyen et 

al.113

2005 0% 225 2.5% 204
259

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Age <50 years Fischer et 

al.114

2000 55% 11 26% 1,369 NR NS † Proportion in 

HCV+ vs. 

HCVNo Adults comprising 

individuals at risk 

for HCV and 

healthcareworker

s enrolled in 

HMO

Age <60 years Kaur et al.116 1996 12% 520 19% 5,853 0.53

(0.40 to 0.71)†

NR Proportion in 

HCV+ vs. 

HCV- with 

references 

to age <60

No 

(protective)

Volunteers from 

general 

population

Race or Ethnicity

Ethnicity: White Nguyen et 

al.113

2005 67.1% 225 57.9% 204 NR 0.15† Proportion 

HCV+ vs. 

HCVNo Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Ethnicity: Black Nguyen et 

al.113

2005 23.9% 225 30.2% 204 NR

Ethnicity: Asian Nguyen et 

al.113

2005 2.3% 225 5.9% 204 NR

Ethnicity: Latino Nguyen et 

al.113

2005 3.6% 225 3.0% 204 NR

Ethnicity: Other Nguyen et 

al.113

2005 3.2% 225 3.0% 204 NR
260

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Ethnicity: White McGinn et 

al.108

2008 11% 83 10% 917 NR 0.38† Proportion in 

HCV+ vs. 

HCVNo In adult primary 

care clinic

Ethnicity: Black McGinn et 

al.108

2008 31% 83 32% 917 NR

Ethnicity: Other McGinn et 

al.108

2008 0% 83 5% 917 NR

Ethnicity: Latino McGinn et 

al.108

2008 58% 83 53% 917 NR

Ethnicity: 

non-Hispanic black

Armstrong et 

al.30

2006 42% 252 26% 13,691 1.9

(0.9 to 3.8)‡

NS Proportion 

HCV+ vs. 

NonHispanic 

white

No General 

population 

aged 20 to 

59 years

Ethnicity: 

Mexican-American

Armstrong et 

al.30

2006 23% 252 32% 13,691 2.6

(1.2 to 5.8)‡

SS Proportion 

HCV+ vs. 

NonHispanic 

white

Yes General 

population 

aged 20 to 

59 years

White/Hispanic Kaur et al.116 1996 7.9% 507 9.2% 5,764 0.57

(0.39 to 0.83)‡

NR Proportion 

HCV+ with 

reference to 

“other”

Yes, 

protect

ive

Volunteers from 

general 

population
261

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size*p-Value**

Comparison made Associated in Study?

Population

Nationality

U.S. Citizen Nguyen et 

al.113

2005 97.7% 225 97.5% 204 NR >0.99† Proportion 

HCV+ vs. 

HCV-

No Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Born outside of U.S. Armstrong et 

al.30

20066% 233 20% 14,787 0.2

(0.08-0.7)‡

SS Born in U.S. 

HCV+

Yes

General 

population 

aged 20 to 

59 years

Born in Southeast 

Asia/Africa

Kaur et al.116 1996 7.7% 559 8.5%

6,069 0.90

(0.50 to 1.64)†

NS Proportion in

HCV+ vs. 

HCV-

No Volunteers from 

general 

population

Language

Preferred language – EnglishMcGinn et 

al.108

2008 89% 83 79% 917 NR 0.03† Proportion in 

HCV+ vs. 

HCV-

Yes In adult primary 

care clinic

Preferred language – SpanishMcGinn et 

al.108

2008 11% 83 20% 917

Occupation

Work contact with 

blood

Fischer et 

al.114

2000 27% 11 20%1,369 NR NS† Proportion in 

HCV+ vs. 

HCV-

No Adults comprising 

individuals at risk 

for HCV and 

healthcareworker s enrolled in 

HMO

Healthcare worker Kaur et al.116 1996 2.9% 568 10.3%6, 185 0.26

(0.19 to 0.35)†

SS Proportion in 

HCV+ vs. 

HCV-

Yes 

(prote

ctive)

Volunteers from 

general 

population
262

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Armed forces Fischer et 

al.114

2000 36% 11 27% 1,369 NR NS† Proportion in 

HCV+ vs. 

HCVNo Adults comprising 

individuals at risk 

for HCV and 

healthcareworker

s enrolled in 

HMO

Services in 

U.S. armed forces

Armstrong et 

al.30

2006 32% 114 31% 4,063 NR NS Prevalence 

HCV+ vs. 

HCVNo Men aged at 

least 20 years in 

general 

population

Job at prison Nguyen et 

al.

113

2005 7.7% 225 1.5% 204 NR 0.002† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Education

Education –

less than 12 years

Armstrong et 

al.30

2006 62% 172 43% 8,634 NR <0.005† Proportion 

HBV+ with 

>12 years

Yes General 

population 

aged at least 

20 years
263

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Education –

6th grade or less

McGinn et 

al.108

2008 10% 83 11% 917 NR 0.62† Proportion 

with level in 

HCV+ vs. 

HCVNo In adult primary 

care clinic

Education –

7-12th grade

McGinn et 

al.108

2008 38% 83 31% 917

Education –

High school 

graduate

McGinn et 

al.108

2008 25% 83 25% 917

Education –

Some college

McGinn et 

al.108

2008 19% 83 19% 917

Education –

At least a college 

degree

McGinn et 

al.108

2008 7% 83 13% 917

Education –

High school or less

Nguyen et 

al.113

2005 46.4% 225 22.7% 204 NR 0.15† Proportion 

HCV+ vs. 

HCVNo Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Education –

Some college

Nguyen et 

al.113

2005 30.6% 225 25.1% 204

Education –

At least a college 

graduate

Nguyen et 

al.113

2005 23.0% 225 52.2% 204
264

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Economic Factors

Homeless, ever Nguyen et 

al.113

2005 9.2% 225 1.0% 204 NR <0.001† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Annual Income

<15,000

Nguyen et 

al.113

2005 13.1% 225 10.2% 204 NR 0.90† Proportion 

HCV+ vs. 

HCVNo Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Annual Income

15,000-25,000

Nguyen et 

al.113

2005 12.6% 225 11.7% 204

Annual Income

25,000-40,000

Nguyen et 

al.113

2005 15.9% 225 19.9% 204

Annual Income

40,000-75,000

Nguyen et 

al.113

2005 26.2% 225 29.1% 204

Annual Income

75,000-100,000

Nguyen et 

al.113

2005 18.7% 225 14.3% 204

Annual Income

>100,000

Nguyen et 

al.

113

2005 13.6% 225 14.8% 204

Family income 

≥2 times poverty 

threshold

Armstrong et 

al.30

2006 31% 278 49% 13,362 NR NS† Proportion 

HCV+ vs. 

HCVNo General 

population
265

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Family income 

1 to 1.9 times 

poverty threshold

Armstrong et 

al.30

2006 30% 278 27% 13,362 NR NS† Proportion 

HCV+ vs. 

HCVNo General 

population

Other

Community – Rural Nguyen et 

al.113

2005 12.8% 225 10.9% 204 NR <0.001† Proportion 

HCV+ vs. 

HCVYes Adults at general 

internal medicine 

clinic (controls) 

and hepatology 

clinic (cases)

Community –

Suburban

Nguyen et 

al.113

2005 52.6% 225 30.6% 204

Community – Urban Nguyen et 

al.113

2005 34.6% 225 58.6% 204

Insurance –

Medicaid

McGinn et 

al.108

2008 77% 83 59% 917 NR <0.001† Proportion 

with 

insurance 

type in 

HCV+ vs. 

HCVYes In adult primary 

care clinic

Insurance –

Medicare

McGinn et 

al.108

2008 12% 83 19% 917
266

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Insurance – Private McGinn et

al.108

2008 10% 83 21% 917

Insurance –

Self Pay

McGinn et 

al.108

2008 1% 83 1% 917

Appointment type –

Scheduled

McGinn et 

al.108

2008 76% 83 78% 917 NR 0.86† Proportion 

with type in 

HCV+ vs. 

HCVNo In adult primary 

care clinic

Appointment type –

Urgent Care

McGinn et 

al.108

2008 17% 83 16% 917

Appointment type –

Data Missing

McGinn et 

al.108

2008 7% 83 6% 917

Children and Adolescents Sex

Male Luban et al.118 2007 65% 43 58% 2,715 1.4 (0.7 to 

2.5)†¶

0.36¶ Proportion 

HCV+ vs. 

HCVNo Children who 

have received 

blood 

transfusions

Race/

Ethnicity

African American Luban et al.118 2007 42% 42 37% 2,474 1.2 (0.7 to 

2.3)†¶

0.51¶ Proportion 

HCV+ vs. 

HCV

No Children who 

have received 

blood 

transfusions

Asian Luban et al.118 2007 0% 42 1.5% 2,474 0.7

(0.05 to 12.6)†¶

0.85¶ Proportion 

HCV+ vs. 

HCV

No Children who 

have received 

blood 

transfusions
267

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison made Associated in Study?

Population

Caucasian Luban et al.118 2007 57% 42 48% 2,474 1.4

(0.8 to 2.7)†¶

0.25¶ Proportion 

HCV+ vs. 

HCV

No Children who 

have received 

blood 

transfusions

Hispanic Luban et al.118 2007 0% 42 3.4% 2,474 0.3

(0.02 to 5.4)†¶

0.44¶ Proportion 

HCV+ vs. 

HCV

No Children who 

have received 

blood 

transfusions

* Odds ratios as reported in publication, unless otherwise specified

** As reported in publication, unless otherwise specified

† Univariate, unadjusted

‡ Multivariate, adjusted for other factors

¶ Calculated by ECRI Institute
268

Table 41. HIV: Nonbehavioral Risk Factors Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated in Study?

Population

Tissue Donors

Co-Morbidity Transfusion

Blood 

transfusion 

recipient or 

donor

Sanchez et 

al.103

2006 Not 

report

ed

(NR)

10 NR 56 NR Not 

significant 

(NS)

Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Nonspecific Exposure

Accidental 

needle stick

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

History of 

transplant

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Surgeries Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Other

Treatment by 

physician in 

last 2 years

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Liver disease Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Medical 

hospitalizations

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Psychiatric 

hospitalizations

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin
269

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated in Study?

Population

Medical 

illnesses

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Medications Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Toxic exposure Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Malaria 

exposure or 

treatment

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Chagas 

disease 

exposure or 

treatment

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Rabies 

exposure

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Heart disease Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Hypertension Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Kidney disease Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Gastrointestina

l disease

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin
270

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated in Study?

Population

Cancer history Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Diabetes 

history

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Pulmonary 

disease

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Rheumatologic 

disease

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Connective 

tissue disease

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Dermatologic 

disease

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Neurologic 

disease

Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

HIV testing Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin

Ocular disease Sanchez et 

al.103

2006 NR 10 NR 56 NR NS Proportion in 

HIV+ vs. HIVNo Potential tissue donors, as reported by next of kin
271

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated in Study?

Population

General Population Other Infection

STD, diagnosis 

of

Mehta et 

al.109

2008 25% 229 NR 16,467 1.56

(1.15 to 2.11)†

NR No STD, 

HIV+

Yes Hospital inpatients and 

outpatients

Herpes simplex 

virus-2 (HSV-2) 

antibody

McQuillan et 

al.101

2006 81% 31 20% 5,570 17.1

(6.9 to 41.9)†¶

<0.001 Proportion in 

HCV+ vs. 

HCVYes General population

HSV-2 

serostatus

Nguyen et 

al.110

2008 71.2% 21 26.9% 1,589 6.46

(2.30 to 18.10)†

Statistically 

significant 

(SS)

Negative Yes General population of 

adults in New York City

History of 

syphilis

Alpert et 

al.115

1996 NR 35 NR 840 NR‡ SS Proportion in 

HCV+ vs. 

HCVYes Adults at emergency 

department room

Infection not 

necessarily 

related to HIV

Alpert et 

al.115

1996 NR 35 NR 840 NR‡ SS Proportion in 

HCV+ vs. 

HCVYes Adults at emergency 

department room

Demographics

General Population Sex

Male Mehta et 

al.109

2008 63% 229 NR 16,467 1.30

(0.98 to 1.71)†

NR Female HIV+ No Hospital inpatients and 

outpatients

Male Zetola et 

al.111

2008 NR 15 NR 1,632 7.68

(0.98 to 60.26)‡

0.053 Female HIV+ No Public hospital 

emergency room patients

Male Nguyen et 

al.110

2008 57.1 21 42.4 1,602 2.01

(0.91 to 4.40)†

NS Female HIV+ No General population of 

adults in New York City
272

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size*p-Value**

Comparison Made

Associated in Study?

Population

Age

Age 18-30 Zetola et 

al.111

2008 NR 15 NR1,632 3.15

(1.03 to 9.61)‡

0.044 Proportion 

HIV+ vs. HIV-

>46 years

Yes Public hospital 

emergency room patients

Age 31-45 Zetola et 

al.111

2008 NR 15 NR1,632 0.76

(0.15 to 2.76)†; 

NR‡

0.732†; 

NS‡

Proportion 

HIV+ vs. HIV-

>46 years

No Public hospital 

emergency room patients

Age 25-39 Mehta et 

al.109

2008 48% 229 NR 16,467 3.22

(1.84 to 5.64)† 

NR Age 15-24, 

HIV+

Yes Hospital inpatients and 

outpatients

Age 40-54 Mehta et 

al.109

2008 42% 229 NR16,467 3.39

(2.24 to 6.91)†

NR Age 15-24 

HIV+

Yes Hospital inpatients and 

outpatients

Age 55+ Mehta et 

al.109

20084% 229 NR 16,467 1.19

(0.50 to 2.85)†

NR Age 15-24 

HIV+

No Hospital inpatients and 

outpatients

Age 35 to 44 

years

Alpert et 

al.115

1996 NR 35 NR 840 NR‡ SS Proportion in 

HCV+ vs. 

HCV-

Yes Adults at emergency 

department room

Race/Ethnicity

Ethnicity, Black Mehta et 

al.109

2008 44% 229 NR 16,467 2.51

(1.61 to 3.93)† 

NR Proportion 

HIV+ vs. 

White

Yes Hospital inpatients and 

outpatients

Black Zetola et 

al.111

2008 NR 15 NR 1,632 1.01

(0.24 to 4.22)†; 

NR‡

0.995†; 

NS‡ 

Proportion 

HIV+ vs. HIV-

vs. White

No Public hospital 

emergency room patients

Black 

race/ethnicity

Nguyen et 

al.110

2008 55.0 20 20.9 1,578 5.53

(1.00 to 30.66)†

SS White 

race/ethnicity

HIV+

Yes General population of 

adults in New York City
273

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated in Study?

Population

Ethnicity, Asian Mehta et 

al.109

2008 0.4% 229 NR 16,467 0.50

(0.07 to 3.68)† 

NR Proportion 

HIV+ vs. HIVNo Hospital inpatients and outpatients

Asian 

race/ethnicity

Nguyen et 

al.110

2008 5.0 20 13.0 1,578 1.12

(0.10 to 12.66)†

NS White 

race/ethnicity

HIV+

No General population of 

adults in New York City

Ethnicity, 

Cape Verdean

Mehta et 

al.109

2008 4% 229 NR 16,467 3.40

(1.16 to 7.15)† 

NR Proportion 

HIV+ vs. HIVYes Hospital inpatients and outpatients

Ethnicity, 

Haitian

Mehta et 

al.109

2008 13% 229 NR 16,467 3.84

(2.24 to 6.60)† 

NR Proportion 

HIV+ vs. HIV

Yes Hospital inpatients and 

outpatients

Ethnicity, 

Other/ 

Not reported

Mehta et 

al.109

2008 11% 229 NR 16,467 3.43

(1.96 to 6.02)†

NR Proportion 

HIV+ vs. HIV

Yes Hospital inpatients and 

outpatients

Hispanic Zetola et 

al.111

2008 NR 15 NR 1,632 2.07

(0.83 to 8.99)†;

NR‡

0.253†; 

NS‡ 

Proportion 

HIV+ vs. 

White

No Public hospital 

emergency room patients

Hispanic 

race/ethnicity

Nguyen et 

al.110

2008 30.0 20 36.0 1,578 2.07

(0.38 to 11.39)†

NS White 

race/ethnicity

HIV+

No General population of 

adults in New York City

Language

Spanish 

speaker

Zetola et 

al.111

2008 NR 15 NR 1,632 0.58

(0.08 to 4.47)†;

NR‡

0.559†; 

NS‡

English 

speakers 

HIV+

No Public hospital 

emergency room patients
274

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated in Study?

Population

Education

Less than 

high school

McQuillan et 

al.101

2006 39% 31 32% 5,889 1.4

(0.66 to 2.8)†¶

0.41 Proportion in 

HIV+ vs. HIVNo General population 

Less than 

high school

Mehta et 

al.109

2008 30% 229 NR 16,467 1.41

(0.96 to 2.07)†

NR At least 

high school/ 

GED, HIV+

No Hospital inpatients and 

outpatients

Economic 

Factors

Homeless Zetola et 

al.111

2008 NR 15 NR 1,632 3.89

(1.32 to 11.45)‡

0.014 Nonhomeless 

HIV+

Yes Public hospital 

emergency room patients

Poverty Index 

<1

McQuillan et 

al.101

2006 41% 27 33% 5,371 1.41

(0.65 to 3.0)†¶

0.38 Proportion 

HIV+ vs. HIVNo General population

Other

No health 

insurance

Mehta et 

al.109

2008 21% 212 NR 16,467 1.66

(1.19 to 2.32)†

NR Insured HIV+ Yes Hospital inpatients and 

outpatients

No health 

insurance

Zetola et 

al.111

2008 NR 15 NR 1,632 1.09

(0.38 to 3.12)†;

NS‡

0.875†; 

NS‡

Insured HIV+ No Public hospital 

emergency room patients

Marital Status

Married/ 

living together

McQuillan et 

al.101

2006 24% 29 53% 5,631 0.28

(0.12 to 0.60)†¶

0.003¶ Proportion 

HIV+ vs. HIVvs. Divorced, 

separated, 

never married

Yes 

(Protec

tive)

General population 

adults
275

Category

Factor Citation Year

Percentage of Infected with FactorTotal Number InfectedPercentage of Uninfected with FactorTotal Number Uninfected

Effect Size* p-Value**

Comparison 

Made

Associated in Study?

Population

Children and Adolescents Sex

Male D’Angelo et 

al.119

1991 15% 13 33% 3,507 NR <0.05† Proportion 

HIV+ vs. HIVNo (protective)

Adolescents attending 

urban hospital

Age

Age >15 years D’Angelo et 

al.119

1991 NR 13 NR 3,507 NR <0.05† Proportion 

HIV+ vs. 

Age <15

Yes Adolescents attending 

urban hospital

* Odds ratios as reported in publication, unless otherwise specified

** As reported in publication, unless otherwise specified

† Univariate, unadjusted

‡ Multivariate, adjusted for other factors

¶ Calculated by ECRI Institute
276

Table 42. GRADE Table for Question 4 (Nonbehavioral Risk Factors)

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

Factors Identified in Original Guideline Exposure to Infected or Suspected Blood

HBV 1 OBS127 One study of embalmers who had a needle stick 

injury during embalming did not find an association 

between needlestick injuries with known or 

suspected HBV positive blood and HBV infection.

127

Low 0 -1 -1 -1 0 0 0 0 Very Low

HCV No studies - - - - - - - - - - Not 

Applicable 

(NA)

HIV - - - - - - - - - - - NA

Signs and Symptoms

HBV No studies - - - - - - - - - - NA

HCV 1 OBS113 Jaundice: Associated in one study113 Low 0 -1 0 0 0 1 0 0 Low

1 OBS104 ALT Reactivity: Associated in one study.104 Low 0 -1 0 0 0 1 0 0 Low

1 OBS30 ALT >40 U/L: Associated in one study30 Low 0 -1 0 0 0 1 0 0 Low

1 OBS114 Elevated liver enzyme: Associated in one study114 Low 0 -1 0 0 0 0 0 0 Very Low

HIV No studies - - - - - - - - - - NA
277

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

Receipt of Blood Transfusion

HBV 3 OBS116,124,126 Blood transfusion was associated with HBV infection 

in a general population,116 as was blood transfusion 

before 1991 in a special population.124 Blood 

transfusion was not associated with HBV in another 

special population study.126

Low 0 0 -1 0 0 0 0 0 Very Low

HCV 8 OBS30,105-107,112-

114,116

All 8 studies associated having had a blood 

transfusion with HCV, and in eight of them the effect 

size was large. It was independently associated with 

HCV with large effect sizes in three blood donor 

studies105-107 and two general population 

studies.112,116 Two additional general population study 

performed univariate analyses only and found large 

effect sizes.113,114 The remaining general population 

study found an independent association between 

having a blood transfusion before 1992 and HCV, 

but the effect size was not large.30

Low 0 0 0 0 0 1 0 0 Moderate

HIV No studies - - - - - - - - - - NA
278

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

Accidental Needlestick with Unknown Blood

HBV 2 OBS103,116 According to data collected from a low-quality nextof-kin, accidental needle sticks were not associated 

with HBV among potential tissue donors.103 A general 

population study found a lower prevalence of HBV 

among people who reported a needlestick.116

Low 0 0 0 -1 0 0 0 0 Very Low

HCV 4 OBS103,105,106,116 According to data collected from a low-quality nextof-kin, accidental needle sticks were not associated 

with HCV among potential tissue donors103 A general 

population study found a lower prevalence of HCV 

among people who reported a needlestick.116 Among 

blood donors who work in a healthcare setting, 

needlestick injuries were not associated with HCV in 

one study,106 but “bloody” needlestick injuries were in 

another.105

Low 0 -1 0 0 0 0 0 0 Very Low

HIV 1 OBS103 According to data collected from a low-quality nextof-kin, accidental needle sticks were not associated 

with HIV among potential tissue donors103

Low -1 -1 0 -1 0 0 0 0 Very Low

Hemodialysis

HBV 2 OBS116,124 Hemodialysis was associated with HBV in one 

general population study116 and one special 

population study.124 Both analyses were univariate, 

and the special population study had a large effect 

size.

Low 0 0 0 0 0 1 0 0 Moderate

HCV 3 OBS112,113,116 In general population studies, “kidney dialysis” was 

associated with HCV in a univariate analysis in one 

study,113 and hemodialysis was associated with HCV 

with a large effect size in multivariate analysis in a 

second study.116 A third study did not find an 

association between hemodialysis and HCV.112

Low 0 0 0 0 0 0 0 0 Low
279

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

HIV No studies - - - - - - - - - - NA

Surgery

HBV 3 OBS103,116,117 The tissue donor study did not associate having had 

surgery with HBV.103 One general population study 

found a lower prevalence of HBV among people who 

had surgery,116 and another found no relationship.117

Low 0 -1 0 0 0 0 0 0 Very Low

HCV 5 OBS103-105,114,116 The tissue donor study did not associate having had 

surgery with HCV.103 One blood donor study did not 

find any association with recent surgery104 and one 

general population study did not find any association 

with history of surgery.114 However, one blood donor 

study did find an independent association between 

HCV and lifetime history of surgery (or sutures).105 A 

general population study found no association.116

Low 0 -1 0 0 0 0 0 0 Very Low

HIV 1 OBS103 The tissue donor study did not associate having had 

surgery with HIV.103

Low -1 -1 0 -1 0 0 0 0 Very Low

Organ Transplant 

Recipients

HBV 2 OBS103,121 HBV was not associated with having an organ 

transplant in one very low-quality study103 or 

a special population study.121

Low 0 0 0 -1 0 0 0 0 Very Low

HCV 1 OBS103 HCV was not associated with having an organ 

transplant in one very low-quality study.103

Low -1 -1 0 -1 0 0 0 0 Very Low

HIV 1 OBS103 HCV was not associated with having an organ 

transplant in one very low-quality study.103

Low -1 -1 0 -1 0 0 0 0 Very Low
280

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

Acupuncture

HBV 2 OBS117,121 Neither the general population study117 nor the 

special population study121 found an association 

between HBV and acupuncture.

Low 0 0 0 0 0 0 0 0 Low

HCV 3 OBS106,107,112 Acupuncture was not associated with HCV infection 

in two studies of blood donors106,107 or one study of a 

general population.112

Low 0 0 0 0 0 0 0 0 Low

HIV No studies - - - - - - - - - - NA

Dental Work

HBV 1 OBS117 Dental work within the last six months was not 

associated with acute HBV in one general population 

study.117

Low 0 0 0 -1 0 0 0 0 Very Low

HCV 2 OBS104,105 Dental work was not associated with HCV among 

blood donors in one study105; nor was having dental 

work in the six months before donation in another.104

Low 0 0 0 0 0 0 0 0 Low

HIV No Studies - - - - - - - - - - NA

Blood Draws

HBV 1 OBS103 The tissue donor study did not find an association 

between HIV testing and HBV, based upon next-ofkin interviews.103

Low -1 -1 0 -1 0 0 0 0 Very Low

HCV 2 OBS103,113 The low-quality tissue donor study did not find an 

association between HIV testing and HCV, based 

upon next of-kin interviews.103 One general 

population study did find an association between 

having had a blood test for HBV and having an HCV 

infection.113 The same study also found that being a 

blood donor was associated with reduced risk of 

HCV.113

Low 0 0 0 -1 0 0 0 0 Very Low
281

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

HIV 1 OBS103 The tissue donor study did not find an association 

between HIV testing and HIV, based upon next of-kin 

interviews.103

Low -1 -1 0 -1 0 0 0 0 Very Low

Household Exposure

HBV 5 OBS117,122-124,126 Having household contact with someone with 

hepatitis was associated with HBV in a special 

population study124, as was a family history of HBV in 

another special population study.123 However, having 

a household member with hepatitis was not 

associated with HBV in a third special population 

study;126 nor was being the wife of a man with HBV in 

a fourth special population study.122 Sharing a razor 

or toothbrush with a household member was not 

associated with HBV in a general population study 

either.117

Low 0 -1 -1 0 0 0 0 0 Very Low

HCV 3 OBS105,113,114 In one blood donor study, living with someone with 

hepatitis or having a relative with hepatitis was not 

associated with HCV , but living with a transfusion 

recipient and sharing a toothbrush or razor with 

person(s) unspecified was.105 In general population 

studies, having at least one family member treated 

for viral hepatitis was not associated with an 

increased risk of HCV in one study,114 but having at 

least one family member with HCV in another study 

was.113

Low 0 -1 0 0 0 0 0 0 Very Low

HIV No studies - - - - - - - - - - NA
282

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

Other Infections

HBV 2 OBS102,124 HBV surface antigen positivity was associated with 

HCV infection among heart donors in one study.102

HBV infection was associated with having had a 

sexually transmitted disease (STD) in a special 

population study.124

Low 0 0 0 0 0 0 0 0 Low

HCV 6 OBS 

30,104,106,107,112,113

HCV was significantly associated with history of STD 

in two blood donor studies106,107 but not a general 

population study.113 HCV was associated with having 

a STD within six months of donating in another blood 

donor study.104 Herpes infection was associated with 

HCV in a general population study30 In addition, HCV 

was associated with seropositivity for other reactive 

infectious diseases in two blood donor studies.104,107

HIV infection was not associated with HCV infection 

upon univariate analysis of a general population 

study.112

Low 0 -1 0 0 0 0 0 0 Very Low

HIV 4 OBS101,109,110,115 In general population studies, HIV infection was 

associated with diagnosis of STD in one study,

109

HSV-2 in two studies,

101,110 and syphilis or other 

infection not apparently related to HIV in another 

study,115

Low 0 0 0 0 0 0 0 0 Low
283

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

Sex

HBV 6 OBS 

116,118,120,121,123,124

In one general population study116 and 2 special 

population studies121,123 males had higher prevalence 

of HBV. Two additional special populations studies 

found no difference120 or a lower prevalence.124

A study of children found no difference.118

Low 0 -1 -1 0 0 0 0 0 Very Low

HCV 9 OBS30,102,104,106-

108,113,114,116

One organ donor study found an increased 

prevalence of HCV in males.102 Among blood donors 

it was in one study107 but not in two others.104,106

Four general population studies found an increased 

risk among males.30,108,113,116 but one other did not.114

Low 0 -1 0 0 0 0 0 0 Very Low

HIV 3 OBS109-111 None of three general population studies associated 

male sex with an increased prevalence of HIV.109-111

Low 0 0 0 0 0 0 0 0 Low

Age

HBV 8 OBS116,120-125,127 Every study tested the association of HBV and age in 

different ways, and the results are inconsistent and 

difficult to compare.

One general population study found an increased risk 

of HBV when >60 years.116 The rest of the studies 

were special population studies. One found an 

association with mean age (with older people having 

greater prevalence of HBV)124 while another did 

not.121 Increased prevalence was associated with 

age younger than 20 years,122 age over 35 years,127

and age over 50 years.125 In another study lower 

prevalence was found in people under 49 years.120

The remaining study did not find any association 

between age and HBV.123

Low 0 -1 -1 0 0 0 0 0 Very Low
284

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

HCV 7 OBS

102,104,106,108,113,114,1

16

Every study tested the association of HCV and age in 

different ways, and the results are inconsistent and 

difficult to compare. The organ donor study found 

that HCV infection was associated with older median 

age.102 One of the blood donor studies associated 

HCV with older mean age,104 the other did not.106

In general population studies, HCV was associated 

with increased mean age108 and decade of birth 

(with people born between 1940 and 1959 having the 

highest prevalence),113 but not age less than 

50 years114 or age less than 60 years.116

Low 0 -1 0 0 0 0 0 0 Very Low

HIV 3 OBS109,111,115 The HIV studies also measured age in different ways, 

complicating comparison. In general these studies 

found young adults to be at the highest risk. One 

study found younger adults (aged 18 to 30) had 

increased prevalence of HIV,111 another found adults 

aged 25 to 40 had higher prevalence of HIV than 

younger people aged 15 to 24 years,109 and the third 

found increased prevalence among adults aged 35 to 

44 years.115

Low 0 -1 0 0 0 0 0 0 Low
285

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

Race or Ethnicity

HBV 2 OBS116,121 White or Hispanic race was associated with lower 

HBV prevalence in a general population study in a 

multivariate analysis116 but not in a special population 

study.121

Low 0 -1 0 -1 0 0 0 0 Very Low

4 OBS29,121,124,125 Non-Hispanic Black race was associated with a 

higher prevalence of HBV in a general population 

study multivariate analysis29 and two special 

population studies124,125 but not another special 

population study.121

Low 0 0 -1 0 0 0 0 0 Very Low

3 OBS29,121,124 Being Mexican-American was not associated with a 

different prevalence of HBV than non-Hispanic White 

race in a multivariate analysis of a general population 

study.29 In special population studies, Hispanic 

ethnicity121 and Hispanic or Latino ethnicity124 were 

not associated with HBV infection.

Low 0 0 -1 0 0 0 0 0 Very Low

1 OBS124 A special population study found an increased 

prevalence of HBV among Asian Americans 

compared with non-Hispanic White Americans.124

Low 0 -1 -1 0 0 0 0 0 Very Low

1 OBS117 Among African American, Caucasian, Asian, and 

Hispanic children who received blood transfusions, 

the prevalence was not significantly different.

Low 0 0 0 -1 0 0 0 0 Very Low
286

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

HCV 7 OBS30,102,104,106-

108,113

Because about half of the studies combined races in 

analyses (their results presented first), the different 

analyses are reported together here. The different 

analysis methods complicate side-by-side 

comparison, but the evidence rating would always be 

‘very low’ for these studies. (These results are all 

presented in the same row because of overlap within 

the studies.)

In organ donors, no relation between race and HCV 

infection was detected.102 Three general population 

studies did not find any relation either.30,108,113

White race was not associated with a difference in 

rate of HCV compared with other races.104

Black race was associated with increased rates of 

HCV compared to Whites in two studies.106,107

Being Asian was associated with having a lower 

prevalence of HCV compared to Whites among 

blood donors.107

Among blood donors, one study found that Hispanics 

had a higher risk of HCV than Whites,107 but another 

did not.104

Low 0 -1 0 0 0 0 0 0 Very Low

HIV 3 OBS109-111 In univariate analyses, two general population 

studies found increased prevalence of HIV among 

people of Black race109,110 but a third did not. 111

Low 0 -1 0 0 0 0 0 0 Very Low

2 OBS109,110 In univariate analyses, neither of two general 

population studies found a difference in HIV 

prevalence in Whites and Asians.109,110

Low 0 0 0 -1 0 0 0 0 Very Low
287

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

National Origin/Birthplace

HBV 5 OBS 

29,116,117,122,123

National origin and birthplace were reported 

differently among studies and most factors cannot be 

considered side-by-side. However, since the rating 

for any factor in this group will be ‘very low’ and there 

is some overlap among studies, we present the 

findings together.

In multivariate analysis of general populations, HCV 

was associated with being born in Southeast Asia or 

Africa in one study.116 A special population study 

found children born in Korea had higher prevalence 

of HBV than children born in the U.S.122 Other special 

population studies did not find significantly different 

rates of Asian Americans born in East Asia 

(excluding China) or Southeast Asia or Pacific 

Islands compared to Asian Americans born in 

China.123

Birth in an area with a high endemic rate or

household exposure to someone born in a high 

endemic rate was not in another general population 

study.117

In multivariate analyses, a general population study29

and a special population study123 found that being 

born in the U.S. was associated was lower 

prevalence of HBV.

Low 0 -1 -1 0 0 0 0 0 Very Low
288

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

HCV 5 OBS 

30,104,107,113,116

One blood donor study did not associate foreign birth 

with HCV,104 but another did in a multivariate 

analysis.107 A general population study found people 

born outside of the U.S. had a lower prevalence of 

HCV.30 Birth in Southeast Asia or Africa was not 

associated with an increased prevalence of HCV in 

another general population study.116 A general 

population study found no association between HCV 

and U.S. citizenship.113

Low 0 -1 0 0 0 0 0 0 Very Low

HIV No studies - - - - - - - - - - NA

Preferred Language

HBV No studies - - - - - - - - - - NA

HCV 1 OBS108 One general population study found an association

between preference of English or Spanish and

HCV.108

Low 0 -1 0 0 0 0 0 0 Very Low

HIV 1 OBS111 One general population study found no difference in

prevalence of HIV among Spanish speakers.111

Low 0 -1 0 -1 0 0 0 0 Very Low
289

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

Occupation

HBV 6 OBS 

29,116,117,121,124,126

Occupation as a health care worker was protective 

against HBV in one general population study116 and 

not associated with HBV in another general 

population study29 or a special population study.121

However, having a healthcare-related job with 

frequent blood exposure was associated with HBV in 

one special population study.124

Another general population study did not associate 

healthcare employment or household contact with 

someone who is a health care worker with HBV,117

and a special population study did not associate 

being a health care worker or the spouse of one with 

HBV.126

Low 0 0 0 0 0 0 0 0 Low

1 OBS29 Ever being in the military was not associated with 

HBV in a general population study.29

Low 0 0 0 -1 0 0 0 0 Very Low

HCV 2 OBS105,114 In any occupation, occupational blood exposure was 

associated with HCV among blood donors in one 

study,105 but work contact with blood was not 

associated with HCV in a general population study.114

Low 0 -1 0 -1 0 0 0 0 Very Low

2 OBS104,116 Medical or dental job with frequent blood contact was 

not associated with HCV in one blood donor study104

and was associated with lower prevalence of HCV in 

a general population study.116

Low 0 -1 0 -1 0 0 0 0 Very Low

2 OBS30,114 Neither of two general population studies associated 

ever having served in the armed forces with 

HCV.30,114

Low 0 0 0 -1 0 0 0 0 Very Low
290

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

2 OBS104,113 Public safety job with frequent blood contact was not 

associated with HCV in one blood donor study.104

Another study did associate having a job at a prison 

with having HCV.113

Low 0 -1 0 0 0 0 0 0 Very Low

HIV No studies - - - - - - - - - - NA

Education

HBV 3 OBS29,121,124 Having less than a high school education was 

associated with HBV in one general population study, 

compared with some college.29 In special population 

studies, one found a higher prevalence of HBV 

among students in 2-year colleges compared to 

those in 4-year colleges,124 and the other study found 

no relationship between years of education and 

HBV.121

Low 0 -1 -1 0 0 0 0 0 Very Low

HCV 5 

OBS30,104,106,108,113

One blood donor study associated less education 

with HCV,104 and another associated having no 

college education with having HCV.106 One general 

population study associated having fewer than 

12 years of education with having HCV,30 but two 

others found no association between educational 

attainment and HCV.108,113

Low 0 -1 0 0 0 0 0 0 Very Low

HIV 2 OBS101,109 Neither of two general population studies found an 

association between having less than a high school 

education and having HIV.101,109

Low 0 0 0 -1 0 0 0 0 Very Low
291

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

Economic Factors

HBV 2 OBS121,125 One special population study did not associate 

homelessness with HBV.121 Another special 

population study did not associate homelessness, 

institutionalization, or other non-independent living 

arrangement with HBV.125

Low 0 0 -1 -1 0 0 0 0 Very Low

HCV 2 OBS30,113 In a general population, ever having been homeless 

was associated with an increased risk of HCV.113

In the same study, annual income was not 

associated with HCV. 

Another general population study did not find any 

association with family poverty level and HCV.30

Low 0 -1 0 -1 0 0 0 0 Very Low

HIV 2 OBS101,111 Being homeless was associated with an increased 

prevalence of HIV in one general population study.111

In another general population study, having a poverty 

index of less than one was not associated with 

HIV.101

Low 0 -1 0 0 0 0 0 0 Very Low

Health Insurance

HBV No studies - - - - - - - - - - NA

HCV 1 OBS108 One general population study associated insurance 

with HCV infection, with people on Medicaid having 

the highest prevalence.108

Low 0 -1 0 0 0 0 0 0 Very Low

HIV 2 OBS109,111 One general population study found a higher 

prevalence of HIV among people with no insurance109

but a second did not.111

Low 0 -1 0 -1 0 0 0 0 Very Low
292

Factor Virus

Quantity and 

Type of 

Evidence Findings

Starting 

Grade

Decrease Grade Increase Grade

GRADE 

of 

Evidence 

for 

Overall QualityConsistencyDirectnessPrecisionPublication BiasLarge MagnitudeDose R

Outcome

esponse

Associated Despite Confounders

Marital Status

HBV 2 OBS29,125 Being divorced or separated was associated with a 

higher prevalence of HBV than any other status in 

one general population study.29 Being currently 

married was not associated with any difference in 

HBV prevalence than any other status in one special 

population study.125

Low 0 0 0 0 0 0 0 0 Low

HCV 1 OBS105 Being married was associated with a lower risk of 

HCV in one blood donor study.105

Low 0 0 0 0 0 0 0 0 Low

HIV 1 OBS101 Being married or cohabitating was associated with a 

lower risk of HIV in one general population study.101

Low 0 0 0 0 0 0 0 0 Low
293

Table 43. Prevalence of Nonbehavioral Risk Factors among Potential Organ Donors

Category Risk Factor Citation Year Prevalence

Number of 

Participants Population

General Population

Serum alanine 

aminotransferase 

level

>40 U/L Armstrong et al.30 2006 9% 13,113 General population, nationwide

Transfusion Blood transfusion 

before 1992 

(participants aged 

20-59 years)

Armstrong et al.30 2006 6% 5,733 General population, nationwide

Blood transfusion 

before 1992 

(participants aged 

at least 60 years)

Armstrong et al.30 2006 16% 2,916 General population, nationwide

Blood transfusion Kaur et al.116 1996 20% 7,539 Volunteers from general population, 

mainly urban

Herpes simplex 

virus infection

Antibodies to 

herpes simplex 

type 2 (HSV-2) 

(ages 18-49)

Armstrong et al.30 2006 19% 5,610 General population, nationwide

Seropositive for 

HSV-2

Nguyen et al.110 2008 28% 1,613 General population in N.Y.C.

STDs STD diagnosis Mehta et al.109 2008 18% 16,696 Patients in urban medical care center
294

Table 44. GRADE for Question 4: Prevalence of Nonbehavioral Risk Factors

Factor

Quantity and Type 

of Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE of 

Evidence for 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose

Outcome

-response

Associated Despite Confounders

Serum alanine 

aminotransferase 

(ALA) level 

>40 U/L

1 OBS*30 In one general population study, 

9% of participants had ALA 

>40 U/L.30

High 0 -1 -1 0 0 0 0 0 Low

Blood 

transfusion

2 OBS30,116 In one general population study, 

the prevalence of ever having 

received a blood transfusion was 

20%.116

In another, 6% of participants 

aged 20-59 years had received a 

blood transfusion before 1992, and 

16% of participants aged at least 

60 had.30

High 0 -1 -1 0 0 0 0 0 Low

Other infection: 

HSV-2

2 OBS30,110 Two studies assessed the 

prevalence of herpes simplex virus2 (HSV-2) in general populations. 

In one, 19% of people aged 18-49 

tested positive.30 In the other, 

28% of adults did.110

High 0 0 -1 0 0 0 0 0 Moderate

Other infection: 

Other STD

1 OBS109 Another study found that 18% of 

adults had had a STD diagnosis.109

High 0 -1 -1 0 0 0 0 0 Low

* Observational study
295

Question 5. What are the test characteristics of the screening methods 

available to detect HIV, HBV, and HCV in potential solid organ donors? 

Do test characteristics differ in particular populations and with donor 

clinical status (i.e., heart beating vs. non-heart beating donors OR adult

vs. pediatric donors)?

The purpose of this question is to summarize information and evidence on 35 diagnostic tests of interest, 

as designated by CDC. A list of these tests of interest is presented in Table 4 of the introductory section. 

Tests of interest include immunoassay tests and nucleic acid tests (NAT) currently used in the U.S. by 

Organ Procurement Organizations (OPOs), as well as, fourth-generation HIV and HCV antibody/antigen 

tests currently in use outside of the U.S. The p24 antigen test for HIV was not included because it is no 

longer used by OPOs. Additionally, an HCV antigen assay used in Europe was not included because the 

assay was licensed after the literature search was conducted. In this question, the following information is 

addressed:

• U.S. FDA approval

• Test format: type of test

• Specimen collection: In particular, whether approved for use in non-heart-beating donors, which 

is primarily a consideration for testing tissue donors. Heart-beating potential organ donors are not 

deceased donors for the purposes of using these tests.

• Window period: The duration of time between infection and when the test can detect infection

• Turnaround time: The duration of time required for the test to be performed

• Diagnostic performance characteristics: In particular, sensitivity and specificity. Measures of 

diagnostic performance are described in greater detail under Analysis Methods.

To address this question, information will be provided in the following order: literature search methods 

and results; list of included peer-reviewed studies and gray literature; samples and study methods of peerreviewed publications; analysis methods used in this question; study assessment; methods of risk of bias

and GRADE assessment of peer-reviewed publications; results summary, followed by data extraction 

tables and GRADE tables.

Peer-reviewed publications and other types of information, as appropriate (see next paragraph), were only 

included if they presented information specific to the tests of interest as listed in Table 4. Information 

regarding any other tests was excluded unless the other test was used in reference to a test of interest. 

Information must have been reported for each test individually, not as part of a multiple-test algorithm, 

because the focus of this question is on the performance of individual tests. Highly selected data sets 

(such as seroconversion panels, or HIV-2 genetic diversity panels) were not included for the assessment 

of diagnostic performance due to both spectrum bias and lack of relevance to performance of the test in 

the U.S. in potential organ donors. Because they are influenced by disease prevalence, predictive values 

and likelihood ratios were only to be collected from studies that calculated them from data from 

reasonably relevant populations to the U.S. (such as clinical applications in a general population, or on 
296

blood donors, not serial dilutions or other laboratory sets, or samples selected for being unusual or 

representative of an endemic area).

Initial searches of bibliographic databases were for diagnostic instruments for HBV, HCV, or HIV. Once 

the list of included tests was generated, additional searches were performed specifically by each test’s 

name. The focus of these searches was to identify clinical literature regarding window period, turnaround 

time, and diagnostic performance characteristics. Because this strategy did not identify information for all 

of the listed tests, we also searched gray literature sources including FDA product labeling information, 

package inserts, manufacturer’s Web sites, and additional sources including the World Health 

Organization (WHO). FDA approval information was searched for all tests as well. We used these 

sources for information on turnaround time and window period but not other diagnostic characteristics 

(e.g., sensitivity and specificity), because these sources of information generally do not report sufficient 

information to enable assessment of the study design, quality, and other factors that impact the outcomes 

and the strength of the evidence. This is a particular concern given the potential for inaccuracy in these 

various sources of literature. Where data from sources other than clinical literature were used for the other 

characteristics, the source is clearly noted in the extraction tables.

Three hundred and forty-eight potentially relevant articles were identified by the bibliographic searches. 

Most were excluded for not reporting on a test on the list of interest (including earlier generations of tests 

of interest). Most of the rest were excluded for not addressing an outcome of interest. Ultimately, 45 peerreviewed publications, each presenting at least one outcome for at least one data set, were included. 

Included publications, including data sets from those publications, and the outcomes they address are 

listed alphabetically by author in Table 45. This table also includes information on what test(s) of interest 

the publications investigated and which data sets were included. Ninety nine pieces of gray literature were 

reviewed for potentially useful data. These included literature from manufacturers’ Web sites (40), the 

internet (6), the Food and Drug Administration (FDA) (23), agencies in the United Kingdom (14), 

agencies from Australia (13), and items from the World Health Organization (3). Data from 26 pieces of 

gray literature reporting window period or turnaround time were included. These sources of information 

are listed in Table 46. Basic information on test format and approved uses were extracted from FDA 

approval documents and, for tests not approved in the U.S., manufacturers’ Web sites.
297

Table 45. Included Data Sets from Peer-reviewed Publications

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Aboud et al.130 2006 HIV 4th 

generation

Vironostika HIV 

Uni-Form II 

Ag/AB

Blood donations and diagnostic 

test samples (clinical HIV 

submissions, antenatal syphilis 

submissions) combined 

(Tanzania)



Aghokeng et al.131 2004 HIV 4th 

generation

Genscreen plus 

HIV Ag/Ab

Blood donations (Cameroon) 

Anderson et al.132 1995 HCV EIA Abbott HCV 

EIA 2.0

Blood donations (U.S.) 

Bamaga et al.133 2006 HCV NAT COBAS 

AmpliScreen 

HCV 2.0

Blood donations (Saudi Arabia) 

Additional Information 

HIV NAT COBAS 

AmpliScreen 

HIV 1.5

Blood donations (Saudi Arabia) 

Additional Information 

Barbe et al.134 1994 HIV EIA, 3rd

generation

Abbott 

recombinant 

HIV-1/HIV-2 

3rd generation 

EIA

Prenatal screening test samples 

(France)



Specificity

False-reactive EIA results Over-selected

HIV positive samples, archived

(France)



Sensitivity

Seroconversion samples 

(Commercial)


298

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Barrera et al.135 1995 HCV EIA, 

3rd

generation

Ortho HCV v3 

ELISA

Seroconversion samples (U.S.) 

Bourlet et al.136 2005 HIV 4th 

generation

AxSYM Ag/Ab 

Combo

Diagnostic samples (France) 

Seroconversion panels

(commercial)



VIDAS DUO 

ULTRA

Diagnostic samples (France) 

Seroconversion panels

(commercial)



Busch et al.137 2005 HIV NAT COBAS 

AmpliScreen 

HIV-1 v. 1.5

Seroconversion samples (U.S.) 

HCV NAT COBAS 

AmpliScreen 

HCV v.2.0

Seroconversion samples (U.S.) 

HCV/HIV 

NAT

ProCleix HIV1/HCV

Seroconversion samples (U.S.) 
299

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Candotti et al.138 2003 HCV NAT, 

HIV NAT

ProCleix HIV1/HCV

Blood donors (U.K.) No reference standard

Known positive samples with 

various subtypes

Overly selected/ specificity 

not appropriately reported 

(above)

Additional information 

Seroconversion panels

(commercial)



Denoyel et al.139 2004 HCV EIA Advia Centaur 

HCV Assay

Blood donors and hospitalized 

patients (France, Germany)



Specificity

Known positives (Commercial 

samples)



Sensitivity

Seroconversion panels

(Commercial)



Interference samples Overly selected

Diepersloot et 

al.140

2000 HBsAg AxSYM HBsAg Clinical submissions (U.S.) 

Galel et al.141 2002 HCV EIA Abbott HCV 

EIA 2.0

Blood donations (U.S.) 

Ortho HCV EIA 

3.0

Blood donations (U.S.) 
300

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Huzly et al.142 2008 anti-HBs Advia Centaur 

anti-HBsAg

Patients and healthcare workers 

(Germany)



Additional Information 

Iqbal et al.143 2005 HIV 4th 

generation

Vironostika HIV 

Uni-Form II 

Ag/AB

Diagnostic samples (India) 

Commercial known-status 

samples



Seroconversion panel (in-house) Window period not 

reported

Jackson et al.144 2002 HCV NAT, 

HIV NAT

ProCleix 

HIV-1/HCV

High risk individuals (U.S.) 

Katsoulidou et 

al.145

2004 HCV NAT, 

HIV NAT

ProCleix 

HIV/HCV

HCV and HIV patients (Greek) Analytic sensitivity only

Seronegative blood donors 

(Greek)

Sensitivity not reported; 

study must report both 

sensitivity and specificity to 

be included

Seroconversion panels (Greek) 

HCV/HIV Co-infection (Greek) Overly selected

Various genotypes (Greek) Overly selected
301

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Kita et al.146 2009 HCV EIA Ortho EIA 3.0 Diagnostic samples (Japan) 

Seroconversion panel

(Commercial)



Advia Centaur 

HCV

Diagnostic samples (Japan) 

Seroconversion panels

(Commercial)



Kleinman et al.147 2005 NAT HBV COBAS 

AmpliScreen 

HBV test

Blood donations (U.S.) 

Kolk et al.148 2002 HCV NAT, 

HIV NAT

ProCleix 

HIV-1/HCV

Seroconversion panels

(Commercial)



Kwon et al.149 2006 HIV 4th 

generation

ARCHITECT 

HIV Ag/Ab 

Combo 

Diagnostic samples with known 

status (Korea)



p24 antigen subtype panel and 

p24 antigen sensitivity panel

(Commercial)

Overly selected

Seroconversion panels

(Commercial)



Low titer antibody panel

(Commercial)

Overly selected
302

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

HIV antibody panel including 

various subtypes (Commercial)

Overly selected –

diagnostic samples with 

known status used 

preferentially

AxSYM HIV 

Ag/Ab Combo

Diagnostic samples with known 

status (Korea)



p24 antigen subtype panel and 

p24 antigen sensitivity panel

(Commercial)

Overly selected

Seroconversion panels

(Commercial)



Low titer antibody panel

(Commercial)

Overly selected

HIV antibody panel including 

various subtypes (Commercial)

Overly selected –

diagnostic samples with 

known status used 

preferentially 

Laperche et al.150 2005 HCV NAT, 

HCV 4th 

generation

COBAS 

AmpliScreen 

HCV v. 2.0

Seroconversion panels

(Commercial)



Blood donations (France) No reference standard

Monolisa HCV 

Ag/Ab Ultra

Seroconversion panels

(Commercial)



Blood donations (France) No reference standard
303

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Laperche et al.151 2005 HCV 4th

generation

Monolisa HCV 

Ag/Ab Ultra

Seroconversion samples (France) 

Laycock et al.152 1997 HCV EIA Abbott HCV v. 

2.0

Potential cornea donors, most of 

whom positive on previous test

(U.S.)



Leon et al.153 1993 HCV EIA Abbott HCV 

EIA 2.0 

Unselected high-risk individuals 

plus known positives from archive

(Spain)



Ly et al.154 2007 HIV 4th

generation

ARCHITECT 

HIV Combo

Negative samples (French) 

Specificity

Positive samples from various 

HIV endemic areas of the world, 

including mosaics and subtypes



Sensitivity

Seroconversion panels

(Commercial)



COBAS Core 

HIV Combi EIA

Negative samples (French) 

Specificity

Positive samples from various 

HIV endemic areas of the world, 

including mosaics and subtypes



Sensitivity

Seroconversion panels

(Commercial)


304

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Genscreen 

Ag/Ab HIV Ultra

Negative samples (French) 

Specificity

Positive samples from various 

HIV endemic areas of the world, 

including mosaics and subtypes



Sensitivity

Seroconversion panels

(Commercial)



VIDAS HIV 

DUO Quick

Seroconversion panels

(Commercial)

 Sensitivity and specificity 

not assessed for this test 

in the publication

VIDAS HIV 

DUO Ultra

Negative samples (French) 

Specificity

Positive samples from various 

HIV endemic areas of the world, 

including mosaics and subtypes



Sensitivity

Seroconversion panels

(Commercial)



Ly et al.155 2006 HBV EIA Advia Centaur 

HBsAg

Reference HBsAg panel (France) 

and HBsAg mutants (commercial)

 No other outcomes of 

interest reported

Ly et al.156 2004 HIV 4th

generation

AxSYM HIV 

Ag/Ab Combo

Positive samples from various 

HIV endemic areas of the world, 

including mosaics and subtypes



Sensitivity

Negative samples 

Specificity
305

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Seroconversion panel

(Commercial)



Genscreen 

Plus Ag/Ab

Positive samples from various 

HIV endemic areas of the world, 

including mosaics and subtypes



Sensitivity

Negative samples 

Specificity

Seroconversion panel

(Commercial)



Murex HIV 

Ag/Ab Combo

Positive samples from various 

HIV endemic areas of the world, 

including mosaics and subtypes



Sensitivity

Negative samples 

Specificity

Seroconversion panel

(Commercial)



Vironostika UniForm II Ag/AbPositive samples from various 

HIV endemic areas of the world, 

including mosaics and subtypes



Sensitivity

Negative samples 

Specificity

Seroconversion panel

(Commercial)


306

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Ly et al.157 2001 HIV 4th

generation

Vironostika HIV 

Uni-Form II 

Ag/AB

Seroconversion panels

(Commercial)



Additional information 

HIV-1 p24 antigen panel infected 

with HIV-1 M subtype B

(Commercial)

Overly selected

Ly et al.158 2001 HIV 4th

generation

AxSYM HIV 

Ag/Ab Combo

Panel with various HIV subtypes, 

including group M subtypes A, B, 

C, D, CRF A/e, F, G, group O

(Commercial)

Sensitivity not reported; 

study must report both 

sensitivity and specificity to 

be included

Seroconversion panel 

(Commercial)



Murex HIV 

Ag/Ab Combo

Panel with various HIV subtypes, 

including group M subtypes A, B, 

C, D, CRF A/e, F, G, group O

(Commercial)

Sensitivity not reported; 

study must report both 

sensitivity and specificity to 

be included

Seroconversion panel 

(Commercial)



VIDAS HIV 

DUO ULTRA

Panel with various HIV subtypes, 

including group M subtypes A, B, 

C, D, CRF A/e, F, G, group O

(Commercial)

Sensitivity not reported; 

study must report both 

sensitivity and specificity to 

be included

Seroconversion panel 

(Commercial)


307

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Owen et al.159 2008 HIV EIA, 3rd

generation

Genetics 

System (GS) 

HIV-1/HIV-2 

plus ) EIA 

Blood and plasma donors, 

including some international 

donors selected for being 

representative of non-subtype-B 

HIV-1 (78% U.S.)



Seroconversion panels

(Commercial)



HIVAB HIV1/HIV-2 (rDNA) 

EIA

Blood and plasma donors, 

including some international 

donors selected for being 

representative of non-subtype-B 

HIV-1 (78% U.S.)



Seroconversion panels

(Commercial)



HIV NAT COBAS 

AmpliScreen 

HIV-1 Test 1.5

Blood and plasma donors, 

including some international 

donors selected for being 

representative of non-subtype-B 

HIV-1 (78% U.S.)

 Seroconversion not 

reported for this test

Romano et al.160 2005 HBV NAT COBAS 

AmpliScreen 

HBV v. 2.0

Blood donors (Probably Italian, 

unclear in publication)

No reference standard

Blood donors with previous 

negative test results elevated 

ALT, chronic HCV

No reference standard
308

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

HBV DNA nucleic acid panel 

(Commercial)

Overly selected

Seroconversion panels

(Commercial)



Saville et al.161 2001 HIV 4th

generation

VIDAS HIV 

DUO ULTRA

Mixed set comprised of U.S.

blood donors (35%), U.S. clinical 

samples (18%), high-incidence 

population in Trinidad (40%), 

STD clinic attendees in 

Bahamas (3%), confirmed HIV-1 

group 0 from Cameroon (0.4%), 

confirmed HIV-2 samples from 

Cote d’Ivoire (0.4%), p24 antigenonly (0.3%)

Diagnostic performance reported 

for all samples together, and 

sample groups separately

 For U.S. sample, PPV & 

NPV only reported for 

patients seeking HIV tests 

(population may have 

different prevalence than 

potential organ donors).

Seroconversion panel 

Seyoum et al.162 2005 HIV 4th

generation

Vironostika HIV 

Uni-Form II 

Ag/AB

Blood donors (Ethiopia) 

Sickinger et al.163 2004 HIV 4th

generation

AxSYM Ag/Ab 

Combo

Blood donors 

Specificity

Hospital patients 

Specificity
309

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Commercial panels tested 

together: Infected with HIV-2 

group M subtypes; Non-staged 

individuals infected with unknown 

HIV-1 subtypes; Individuals with

HIV-2 living in endemic areas; 

High-risk individuals; interference 

panel



Sensitivity

Seroconversion panels 

Sun et al.164 1999 HCV NAT AmpliScreen 

HCV 2.0

Blood donors No outcomes of interest 

reported

Known positive, genotypes 1a, 

1b, 2, 2b, 3a, 5a, 6a, from 

archives

No outcomes of interest 

reported

Seroconversion panel 

(Commercial)



Van Binsbergen et 

al.165

1998 HIV 4th

generation

Vironostika HIV 

Uni-Form II 

Ag/AB

HIV-1 sub-typed samples with 

A through F, and group O 

(Yaounde and Cameroon)

Overly selected (sub-types 

only)

Samples with human anti-mouse 

antibody

Overly selected; not 

clinical samples

Seroconversion panels

(Commercial)


310

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Van Binsbergen et 

al.166

1999 HIV 4th

generation

Vironostika HIV 

Uni-Form II 

Ag/AB

Worldwide HIV-1 Performance 

Panel, including various 

subgroups (group M subtypes A 

through F, and group O) 

(Commercial)

Specificity not reported; 

study must report both 

sensitivity and specificity to 

be included

Seroconversion panels 

(Commercial) 



Vargo et al.128 2002 HCV NAT, 

HIV NAT

ProCleix 

HIV/HCV

Known positive HIV-1 samples 

(Commercial)



Sensitivity

Known positive HCV samples 

(Commercial)



Sensitivity

Co-infected HIV-1/HCV samples 

Sensitivity

Negative samples 

Specificity

Seroconversion panels 

(Commercial)



Vrielink et al.167 1995 HCV EIA Ortho 3.0 HCV 

EIA

Volunteer random blood donors 

(Dutch)



Vrielink et al.168 1995 HCV EIA Ortho 3.0 HCV 

EIA

Blood donor samples submitted 

for characterization because of 

initial positive result, patients with 

non-A non-B hepatitis, multiplytransfused patients



Sensitivity
311

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Positive blood donors’ serial 

dilutions

No outcomes of interest

First-time blood donors 

Specificity

Weber et al,169 2002 HIV 4th

generation

VIDAS DUO 

ULTRA

Seroconversion panels 

Dilutions of cell culture 

supernatants with different HIV-1 

subtypes (incl. B, E, F, G, H, O)

Overly selected, not 

clinical samples

Interference panel Overly selected

Additional Information 

Weber et al.170 2002 HIV 4th

generation

COBAS Core 

HIV Combo EIA

Seroconversion panels 

Acute infection panels Overly selected

Known positive samples from 

patients in different stages of 

HIV-1 and HIV-2

Overly selected

Sub typed samples from different 

geographical locations

Overly selected

Dilutions of cell culture 

supernatants from cells infected 

with different HIV-1 subtypes

Overly selected
312

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Performance panels, low-titer or 

mixed titer (Commercial)

Overly selected

Blood donor samples, unselected

(European)



Specificity

Diagnostic samples, unselected 

(European)



Sensitivity

Interference panel Overly selected

Willoughby et al.171 1989 HIV 4th

generation

Coulter HIV-1 

p24 Ag Assay

Blood donors, known seropositive 

samples, spinal cord fluid, 

interference samples

No other outcomes 

reported

Additional Information 

Yang et al.172 2001 HIV NAT COBAS 

AmpliScreen 

HIV-1 v.1.5

Known negative blood donors Specificity not reported; 

study must report both 

sensitivity and specificity to 

be included

Seroconversion panel 

Group M subtype panel Overly selected

Interference panel Overly selected
313

Citation Year

Test 

Category Index Test(s) Data Set(s)

Outcomes Included

Reason Sample Set 

Excluded

Diagnostic Performance Window 

Period

Turnaround 

Time

Sensitivity & SpecificityPredictive ValuesLikelihood Ratios

Yang et al.173 1999 HIV NAT AmpliScreen 

HIV-1 v.1.5

Genotype panel Overly selected

Blood donors, seronegative Sensitivity not reported; 

study must report both 

sensitivity and specificity to 

be included

Interference panels Overly selected

Seroconversion panels 
314

Table 46. Included Data Sets from Gray Literature

Citation Year Test Category Test(s) of Interest Data Set(s) Included

Outcomes Included

Literature Type

Window 

Period

Turnaround 

Time

Abbott 

Laboratories174

Download 

9/2009

4th generation 

HIV EIA

ARCHITECT HIV Ag/Ab Combo (None)  Manufacturer Web site 

product information 

(Seroconversion also 

reported but only for 

selected 3 or 31 panels, 

so not included)

BioMerieux 

Diagnostics175

Downloaded 

9/2009

HIV 

4th generation

VIDAS HIV DUO ULTRA 16 seroconversion panels  Manufacturer Web site 

product information

BioMerieux 

Diagnostics176

Downloaded 

9/2009

HIV 

4th generation

VIDAS HIV DUO QUICK 25 seroconversion panels  Manufacturer Web site 

product information

Burgess and 

Perry177

2008 4th generation 

HIV EIA

ARCHITECT HIV Ag/Ab Combo 

Assay

AxSYM HIV Ag/Ab Combo

GENSCREEN Ultra HIV Ag/Ab

Murex HIV Ag/Ab Combination

Vironostika HIV Uni-Form II 

Ag/Ab

20 seroconversion panels, with 

comparative data for 18 of them

  Independent public health 

laboratory evaluation

Burgess et al.178 2001 4th generation 

HIV EIA

AxSYM HCV version 3.0 22 seroconversion panels  Independent public health 

laboratory evaluation

Cooray et al.179 2003 4th generation 

HIV EIA

AxSYM HIV Ag/Ab Combo

Murex HIV Ag/Ab Combination

Genscreen PLUS HIV Ag/Ab

Vironostika HIV Uni-Form 

Ag/Ab

35 seroconversion panels   Independent public health 

laboratory evaluation
315

Citation Year Test Category Test(s) of Interest Data Set(s) Included

Outcomes Included

Literature Type

Window 

Period

Turnaround 

Time

Coulter 

Corporation180

Downloaded 

9/2009

HCV 

4th generation

Coulter HIV-1 p24 Antigen 

Assay

5 seroconversion panels  Manufacturer Web site 

product information

Curtis et al.181 2006 4th generation 

HIV EIA

Genscreen ULTRA HIV Ag/Ab

Murex HIV Ag/Ab Combo

Vironostika HIV Uni-Form 

Ag/Ab

21 seroconversion panels   Independent public health 

laboratory evaluation

Dean et al.182 2006 HCV 

4th generation

MONOLISA HCV Ag/Ab ULTRA 19 seroconversion panels  Independent public health 

laboratory evaluation

Delieu et al.183 2001 4th generation 

HIV EIA

Murex HIV Ag/AB Combination 

EIA

39 seroconversion panels   Independent public health 

laboratory evaluation

FDA approval 

documentation184

Package 

insert 

approved 

5/2007

HCV NAT COBAS AmpliScreen HCV Test 9 seroconversion panels  FDA documentation 

including package insert

FDA approval 

documentation185

Package 

insert 

approval 

8/2007

HBV NAT COBAS AmpliScreen HBV Test

Ortho HBsAg

40 seroconversion panels  FDA documentation 

including package insert

FDA approval 

documentation186

Package 

insert 

approved 

12/2004

HBV HBc ADVIA Centaur HBc 7 seroconversion panels  FDA documentation 

including package insert

FDA approval 

documentation187

Package 

insert 

approved 

10/2005

HBV Core PRISM HBcore None reported  FDA documentation 

including package insert
316

Citation Year Test Category Test(s) of Interest Data Set(s) Included

Outcomes Included

Literature Type

Window 

Period

Turnaround 

Time

FDA approval 

documentation188

Package 

insert 

approved 

12/2004

HCV assay ADVIA Centaur HCV Assay

Ortho HCV v. 3

23 seroconversion panels  FDA documentation 

including package insert

FDA approval 

documentation189

Package 

insert 

approved 

5/2005

HBV HBsAg ADVIA Centaur HBsAg 6 seroconversion panels  FDA documentation 

including package insert

FDA approval 

documentation190

Package 

insert 

approved 

7/2004

3rd generation 

HIV EIA

HIVAB HIV-1/HIV-2 (rDNA) EIA 9 seroconversion panels  FDA documentation 

including package insert

FDA approval 

information191

Package 

insert 

approved 

2/2002

HIV/HCV NAT ProCleix HIV-1/HCV Assay 10 HIV seroconversion panels

10 HCV seroconversion panels

 FDA documentation 

including package insert

FDA approval 

information192

Current 

package 

insert 

approved 

5/2007

HIV NAT COBAS AmpliScreen HIV-1 

Test

Coulter HVI-1 p24 Ag test

41 seroconversion panels  FDA documentation 

including package insert

FDA approval 

information193

Package 

insert 

approved 

1/2003

HBsAg EIA Genetic Systems HBsAg EIA 

3.0

21 seroconversion panels  FDA documentation 

including package insert

FDA approval 

information194

Package 

insert 

approved 

2006

HBsAg Assay AxSYM HBsAg Assay 15 seroconversion panels  FDA documentation 

including package insert
317

Citation Year Test Category Test(s) of Interest Data Set(s) Included

Outcomes Included

Literature Type

Window 

Period

Turnaround 

Time

FDA approval 

information195

Package 

insert 

approved 

8/2003

3rd generation 

HIV EIA

Genetic Systems HIV-1/HIV-2 

Plus O EIA

50 seroconversion panels  FDA documentation 

including package insert

Innogenetics196 Downloaded 

9/2009

HCV 4th

generation

Innotest HCV Ab IV

Ortho HCV 3.0

30 seroconversion panels  Manufacturer Web site 

product information

Ortho-Clinical 

Diagnostics197

Downloaded 

9/2009

HBV HBsAg Genetic Systems HBsAg EIA 

3.0

21 seroconversion panels  Manufacturer Web site 

product information

White and 

Perry198

2003 HBc Ortho HBc ELISA Test System 4 seroconversion panels  Independent public health 

laboratory evaluation

World Health 

Organization199

2004 4th generation 

EIA

Enzygnost HIV Integral II

Genscreen Plus HIV Ag/Ab

Murex HIV Ag/Ab Combination

Vironostika HIV Uni-Form II 

Ag/Ab

8 seroconversion panels   Independent public health 

laboratory evaluation
318

Samples and Study Methods in Peer-reviewed Publications

Table 47 shows a summary of the general study and sample characteristics for each of the included peerreviewed publications. We sometimes refer to the tested blood sets as samples because not all came from 

clinical populations (most were purchased from laboratory supply companies). Publications were first 

categorized by whether or not the test(s) of interest are currently in use by U.S. O.P.Os. Tests were further 

categorized as immunoassays (e.g., EIA) or nucleic acid tests (NAT). All were further subdivided by 

which virus(es) they are intended to detect. (Where studies addressed tests of interest from more than one 

category, the study information is repeated for each category. The test pertinent to the category is bolded.) 

For each of the publications, information regarding the national origin of the samples, the sources(s) of 

the samples, how the samples were selected, references standard(s) employed, and source(s) funding 

(if reported) is listed. Many of these studies were conducted internationally, and some conducted 

domestically used international samples. Although most of the commercial samples were purchased from 

U.S. companies, many of those U.S.-purchased panels had samples from all over the world. None of the 

sources of samples were potential organ donors. Publications used samples from a variety of sources (and 

often, multiple sources within the same publication), including clinical samples from routine screening or 

diagnosis, blood donor samples, and commercially purchased or archived known-status samples and 

seroconversion panels. Correspondingly, the prevalence of infection ranged widely, from a very small 

fraction of 1% to over 60% (not including seroconversion panels or all known-positive sets). Some 

sample sets were unselected (i.e., part of a consecutive or randomly selected sample), while others were 

selected for known characteristics (e.g., known infection or known non-infection, known seroconversion). 

All samples appear to have been drawn from living individuals, with the exception of one publication. 

None appear to have specifically studied pediatric populations. Everything from previous-generation EIA 

to NAT to exhaustive algorithms were employed as reference standards. Well-defined commercially 

purchased samples did not always have the reference standard explicitly described in the study, but those 

that did typically used multiple confirmatory analyses and quantitative analyses to determine the sample 

status. Some studies report funding from the manufacturer and some appear to have been publicly funded 

through federal health organizations, but for most the funding source was not reported.

In gray literature, window periods were always determined relative to other tests using seroconversion 

panels. Methods used to determine turnaround time were not reported.
319

Table 47. General Study and Sample Characteristics of Peer-reviewed Studies

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

Tests currently in use in U.S. Organ Procurement Organization (OPO): Immunoassays

HIV EIA

3rd generation

Abbott 

recombinant 

HIV-1/HIV-2 

3rd generation 

EIA

Barbe et

al.134

1994 France Obstetric samples 

(n = 1,546) (for 

specificity)

Prevalence 0.05%

HIV positive samples 

(n = 7) (for sensitivity)

Seroconversion 

samples (8 samples)

Unselected 

prenatal screening 

at an OB/GYN

office

Seroconversion 

and infected 

samples selected 

for known 

properties

Known status for 

seroconversion 

panel

For clinical 

samples, 

bioMerieux Vidas 

test with Western 

blot (WB) 

confirmation

No None reported

Genetics 

System (GS)

HIV-1/HIV-2 

plus EIA;

HIVAB 

HIV-1/HIV-2 

(rDNA) EIA 

(Abbott); 

COBAS 

AmpliScreen 

HIV-1 Test 1.5

Owen et 

al.159

2008 Mostly U.S., also 

Cameroon and 

unspecified 

international 

samples with 

non-subtype-B 

HIV-1

Tested together: 

U.S. blood donors 

(n = 997), 

international donors 

(n = 97).

samples from 

Cameroon (n = 114)

HIV-2 specimens from 

Ivory Coast (n = 32)

and commercial HIV-2 

specimens (n = 2)

Prevalence 56% (53%

HIV-1, 2% HIV-2)

Seroconversion 

panels (15 panels, 

183 specimens)

For defined 

properties (at left); 

all commercially 

purchased

Known status for 

seroconversion 

and purchased 

panels

For negatives, 

consensus 

negative with 

other screening 

tests

Confirmation of 

positives with 

Western blot

No Not reported, but 

all authors 

affiliated with 

Centers for 

Disease Control 

(CDC)
320

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

HBsAg AxSYM 

HBsAg

Diepersloot 

et al.140

2000 U.S. Clinical submissions 

for HBV tests

(n = 200)

Prevalence: 6%

Not reported, but 

study states 

selection was 

prospective

Abbott Imx and 

DPC IMMULITE 

assays

AxSYM total 

anti-HBV core 

assay for 

discrepancies

No None reported

anti-HBs Advia 

Centaur antiHBsAG 

Huzly et 

al.142

2008 Germany Patients and

healthcare workers

(n = 200)

Prevalence of surface 

antigen (including 

vaccinated individuals 

73%); Core antigen 

12%

Unselected Bitros anti-HBs

Roche Elecsys 

anti-HBs

Liasion anti-HBs

Abbott Architect 

anti-HBs

ETI-AB-AUK-3

Enzygnost 

anti-HBs

Monolisa 

anti-HBS

AxSYM AUSAB

No None reported
321

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

HCV EIA Abbott HCV 

EIA 2.0

Anderson et 

al.132

1995 U.S. Blood donors

(n = 21,431)

Prevalence 0.6%

Unselected Ortho Anti-HCV 

2.0

For confirmation 

of positives, 

Matrix HCV

anti-HCV RIBA-II

PCR

No None reported

Laycock et 

al.152

1997 U.S. Potential cornea 

donors (n = 101)

Prevalence: 62%

Selected from 

archives, but 

apparently not for 

any particular 

characteristics

Matrix-HCV RIBA No Grants from 

Mid-America 

Transplant 

Association and 

Research to 

Prevent 

Blindness Inc.

Leon et al.153 1993 Spain High-risk individuals 

(n = 398)

Prevalence 2%

Known positive blood 

donations from 

archive (n = 102)

Overall prevalence 

22%

High-risk 

individuals 

unselected (men 

who have sex with 

men, inmates, 

“mentally 

retarded”)

Blood donors 

who were known 

to have tested 

positive on first 

generation HCV 

ELISA test

All samples 

tested by 

11 methods, 

Negatives by 

consensus

Those reactive in 

at least one also 

tested with 

supplemental 

assays to confirm 

positives

No Not reported, but 

performed at a 

national 

microbiology 

center
322

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

Abbott HCV 

EIA 2.0

Ortho HCV 

EIA 3.0

Galel et 

al.141

2002 U.S. Blood donors

(n = 5.5 ×106)

Previously 

negative

COBAS 

AmpliScreen HCV 

test 2.0

No Not reported. 

Abbott performed 

PRISM testing, 

Roche Molecular 

provided RNA 

testing and 

equipment

Advia 

Centaur HCV 

Assay

Denoyel et 

al.139

2004 Noncommercial 

samples from 

Europe or U.S.

Seroconversion 

samples 

commercial

Seroconversion 

panels (20 panels)

For specificity, blood 

donors (n = 5,015) 

and people (n = 213)

Prevalence 0.4%

For sensitivity, 

samples presumed 

infected (n = 472)

Commercial 

panels and 

positives selected 

for known 

properties. 

Blood donors and 

hospitalized 

patients 

unselected

Commercial 

panels: Known 

samples

Blood donors and 

hospitalized 

patients: Abbott 

AxSYM 3.0 and 

verification of 

positives with 

RIBA immunoblot 

testing

No None reported
323

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

Advia 

Centaur HCV

Ortho 3.0 EIA

Kita et al.146 2009 Clinical samples 

from Japan.

Seroconversion 

panels 

purchased from 

U.S. companies.

Clinical submissions 

for HCV tests 

(n = 500)

Prevalence: 2.6%

Commercially 

purchased

seroconversion panels 

(2 series)

Clinical samples 

appear to be 

unselected.

Seroconversion 

panels selected

seroconversion

Panels: known 

status.

Clinical samples 

compared among 

other tests to 

define negativity 

(Ortho Quick 

Chaser HCV Ab, 

VITROS HCV, 

Ortho HCV Ab PA 

Test II, Imx HCV 

Dainapak-II, 

Architect HCV, 

Lumipulse IT 

Ortho HCV, 

Lumipulse Presto 

HCV) and 

confirmatory 

analyses to 

define positivity 

(RIBA III, or 

RNA PCR)

No None reported

Ortho 3.0 

HCV EIA

Barrera et 

al.135

1995 U.S. Serial specimens from 

individuals who 

developed posttransfusion HCV

(n = 21)

For 

seroconversion

Known status No None reported, 

but most of the 

authors employed 

at Ortho 

Diagnostic 

Systems
324

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

Vrielink et 

al.167

1995 The Netherlands Blood bank archives 

(n = 2,153)

Prevalence <1%

Unselected blood 

donors

For specificity, 

Ortho 2.0 HCV 

EIA

For sensitivity, 

Ortho 2.0 HCV 

EIA, PCR, RIBA-2

No None reported

Vrielink et 

al.168

1995 The Netherlands Tested together: 

Repeatedly positive 

blood donors (403 

samples), non-A nonB hepatitis patients 

(212 samples),

multiply-transfused 

patients (253 

samples), unselected 

first-time donors 

(1,055 samples)

Prevalence 21%

For properties at 

left

PCR, RIBA-2 No None reported

Tests currently in use in U.S. Organ Procurement Organizations (OPO): NAT

HIV NAT COBAS 

AmpliScreen 

HCV 2.0; 

COBAS 

AmpliScreen 

HIV 1.5

Bamaga et 

al.133

2006 Saudi Arabia Blood donors

(n = 3,288) 

Prevalence: 0.2%

Unselected blood 

donors

Abbott AxSYM 

HCV 3.0, 

Enzygnost HIV

No None reported
325

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

COBAS 

AmpliScreen 

HIV-1,

COBAS 

AmpliScreen 

HCV, ProCleix 

HIV-1/HCV

Busch et 

al.137

2005 U.S. Archived plasma 

donations with 

confirmed viremia 

and/or seroconversion 

(12 HIV

seroconversion 

panels, 12 HCV 

seroconversion 

panels)

Serial samples 

available at least 

two weeks before 

samples became 

quantifiable, with 

short collection 

intervals (less 

than one week)

Known-status 

seroconversion 

panels (no 

negative 

samples)

No Funded in part by 

National Heart, 

Lung, and 

Blood Institute 

contracts.

Genetics 

System (GS) 

HIV-1/HIV-2 

plus ) EIA; 

HIVAB 

HIV-1/HIV-2 

(rDNA) EIA 

(Abbott); 

COBAS 

AmpliScreen 

HIV-1 Test 1.5

Owen et 

al.159

2008 Mostly U.S., also 

Cameroon and 

unspecified 

international 

samples with 

non-subtype-B 

HIV-1

Tested together: 

U.S. blood donors 

(n = 997), 

international donors 

(n = 97).

samples from 

Cameroon (n = 114)

HIV-2 specimens from 

Ivory Coast (n = 32)

and commercial HIV-2 

specimens (n = 2)

Prevalence 56% 

(53% HIV-1, 

2% HIV-2)

Seroconversion 

panels(5 panels, 

183 specimens)

For defined 

properties (at left); 

all commercially 

purchased

Known status for 

seroconversion 

and purchased 

panels

For negatives, 

consensus 

negative with 

other screening 

tests

Confirmation of 

positives with 

Western blot

No Not reported, but 

all authors 

affiliated with 

Centers for 

Disease Control 

(CDC)

COBAS 

AmpliScreen 

HIV-1 v.1.5

Yang et 

al.173

1999 Commercial 

panels

Seroconversion 

panels (10 panels)

For 

seroconversion

Known status No None reported, 

but all authors 

affiliated with 

Roche Molecular 

Systems, Inc.
326

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

Yang et 

al.172

2001 Commercial 

panels

Seroconversion 

panels (10 panels)

For 

seroconversion

Known status No None reported, 

but all authors 

affiliated with 

Roche Molecular 

Systems, Inc.

HCV NAT COBAS 

AmpliScreen 

HCV 2.0;

COBAS 

AmpliScreen 

HIV 1.5

Bamaga et 

al.133

2006 Saudi Arabia Blood donors

(n = 3,288) 

Prevalence: 0.2%

Unselected blood 

donors

Abbott AxSYM 

HCV 3.0, 

Enzygnost HIV

No None reported

COBAS 

AmpliScreen 

HIV-1,

COBAS 

AmpliScreen 

HCV, ProCleix 

HIV-1/HCV

Busch et 

al.137

2005 U.S. Archived plasma 

donations with 

confirmed viremia 

and/or seroconversion 

(12 HIV

seroconversion 

panels, 12 HCV 

seroconversion 

panels)

Serial samples 

available at least 

two weeks before 

samples became 

quantifiable, with 

short collection 

intervals (less 

than one week)

Known-status 

seroconversion 

panels 

(no negative 

samples)

No Funded in part by 

National Heart, 

Lung, and Blood 

Institute 

contracts. 

COBAS 

AmpliScreen 

HCV v. 2.0

Monolisa HCV 

Ag/Ab Ultra

Laperche et 

al.150

2005 Commercial 

seroconversion 

panels from U.S.

companies

Commercial 

seroconversion panels 

(10 panels, 

107 samples)

Seroconversion 

panels for defined 

properties 

(seroconversion)

For 

seroconversion

No Not reported, 

appears to be 

French public 

source
327

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

COBAS 

AmpliScreen 

HCV 2.0

Sun et al.164 1999 Commercial 

panels

Commercial 

seroconversion panels 

(5 panels)

For 

seroconversion 

Known status No None reported, 

but all authors 

affiliated with 

Roche Molecular 

Systems, Inc.

HBV NAT COBAS 

AmpliScreen 

HBV

Kleinman et 

al.147

2005 U.S. Blood donors

(n = 581,790)

Prevalence: 0.02%

All donors 

meeting standard 

criteria included

HBsAg Auszyme 

and anti-HBc EIA 

(Abbott 

Laboratories) or

HBsAg test 

system 2 and 

anti-HBc total 

(Ortho Clinical 

Diagnostics).

Discordant 

results: ID NAT 

with the 

AmpliScreen HBV 

test, alternative 

NAT, and DNA 

quantification.

No Roche Molecular 

Systems

Romano et 

al.160

2005 Commercial Seroconversion 

panels (5 panels) 

(commercial)

For 

seroconversion

Known status No None reported
328

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

HIV-1 and 

HCV NAT

COBAS 

AmpliScreen 

HIV-1,

COBAS 

AmpliScreen 

HCV, 

ProCleix HIV1/HCV

Busch et 

al.137

2005 U.S. Archived plasma 

donations with 

confirmed viremia 

and/or seroconversion 

(12 HIV

seroconversion 

panels, 12 HCV 

seroconversion 

panels)

Serial samples 

available at least 

two weeks before 

samples became 

quantifiable, with 

short collection 

intervals (less 

than one week)

Known-status 

seroconversion 

panels 

(no negative 

samples)

No Funded in part by 

National Heart, 

Lung, and 

Blood Institute 

contracts. 

ProCleix 

HIV-1 /HCV

Candotti et 

al.138

2003 Commercial Commercial 

seroconversion panels

(2 panels)

For 

seroconversion

Known status No National Blood 

Service NAT 

steering

committee and 

Chiron 

Corporation

Jackson et 

al.144

2002 U.S. High-risk individuals’ 

archived samples 

(n = 539)

Prevalence: 

2.2% HIV only, 

48% HCV only, 

2% co-infected

At high risk for 

HIV and HCV

“Standard”

serological test, 

p24 antigen test, 

alternative NAT, 

follow up 

if needed

No Not reported, but 

3 co-authors 

employed at 

Gen-Probe Inc. 

Katsoulidou 

et al.145

2004 Greece Seroconversion 

panels from dialysis 

patients (25 panels)

For 

seroconversion

Known status No None reported, 

but Chiron Corp. 

provided 

reagents.

Kolk et al.148 2002 Commercial Commercial 

seroconversion panels

(26 panels HIV, 

24 panels HCV)

For 

seroconversion

Known status No In part by 

National Heart, 

Lung, and 

Blood Institute. 

Authors 

employed at 

Gen-Probe Inc.
329

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

Vargo et 

al.128

2002 U.S. 

Commercial

Blood donors 

(n = 191,200) 

for specificity

Commercial:

Positive samples 

(n = 2,015: 

1,040 HIV infected, 

1,015 HCV infected)) 

for sensitivity

Seroconversion 

panels (10 panels 

HIV-1 and 10 HCV)

Blood donors 

appear to be 

unselected

Panels for 

seroconversion

Serology, with 

WB and/or 

immunofluoresce

nce and/or p24 

Ag test for HIV 

and RIBA for 

HCV to confirm 

positives

Panels and 

infected samples: 

Known status

Yes Not reported but 

some authors 

affiliated with 

Chiron Corp.

Tests currently not in use in U.S. Organ Procurement Organization (OPO): Fourth Generation Immunoassays

HIV 

4th generation

EIA

ARCHITECT 

HIV Ag/Ab 

Combo, 

AxSYM HIV 

Ag/Ab 

Combo

Kwon et 

al.149

2006 Korea

Commercial

Korean samples in 

collection at university 

laboratory 

(143 infected, 

412 uninfected)

Three commercial 

seroconversion panels 

(n = 21)

Panels selected 

for defined 

properties

(positive, 

negative, 

seroconversion)

Known status for 

commercial 

panels

Negatives by 

other Ab/Ag test 

consensus

Clinical samples 

Western blot 

confirmed.

No None reported
330

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

ARCHITECT 

HIV Combo

Cobas Core

HIV Combi 

Genscreen 

Ag/Ab HIV 

Ultra

VIDAS HIV 

DUO Quick

VIDAS HIV 

DUO Ultra

Ly et al.154 2007 France

Commercial

Lab archives: 

For specificity: 

HIV negative samples 

(1,005)

For sensitivity: 

known positive 

samples from 

endemic areas (669)

Seroconversion 

panels (24 panels), 

commercial

For known 

characteristics 

(positive, 

negative, 

seroconversion) 

Known status for 

commercial 

panels and 

positives

Samples were 

considered 

negative if all 

samples run were 

negative

No None reported

AxSYM 

Ag/Ab 

Combo 

VIDAS DUO 

ULTRA

Bourlet et 

al.136

2005 Serum samples 

from France

Commercial 

panels

Serum samples 

submitted to university 

hospital microbiology 

department 

(n = 1,443)

Prevalence: 0.8% 

Commercial panel:

Seroconversion 

panels (14 panels, 

n = 112)

Serum samples 

consecutive. 

Seroconversion 

panels selected 

for defined 

properties 

(seroconversion).

Panels known 

status.

Serum sample 

positives 

confirmed by 

Western blot or 

HIV-1 antigen 

assay or 

HIV-1 RNA assay

Negative if 

all three 

4th generation 

tests of interest 

negative.

No None reported
331

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

AxSYM HIV 

Ag/Ab 

Combo, 

Genscreen 

Plus Ag/Ab

Murex HIV 

Ag/Ab 

Combo, 

Vironostika 

Uni-Form II 

Ag/Ab

Ly et al.156 2004 Including U.S., 

France, 

Cameroon, 

Ghana, Uganda, 

U.K., Brazil, 

South Africa, 

Thailand, 

Argentina

25 seroconversion 

panels (176 samples)

Antibody positive 

samples 

(669 samples) 

for sensitivity

Unselected negatives 

(1,005 samples) 

(for specificity)

For defined 

properties 

(positive, 

negative, 

seroconversion)

Known status No None reported

AxSYM 

Ag/Ab 

Combo

Sickinger et 

al.163

2004 Various panels 

purchased from 

U.S., Germany.

Blood donations 

and diagnostic 

samples possibly 

German 

because 

diagnosis 

confirmation held 

to German 

standards.

Commercial panels

tested together for 

sensitivity: 

HIV-1+ (n = 453), 

HIV-2 from endemic 

area (n = 108),

HIV+ not staged or 

genotyped (n = 107)

HIV-1 group O 

(n = 19)

HIV-1 with p24 Ag 

(n = 50)

Blood donors 

(n = 7,900) 

(specificity)

Diagnostic 

submissions

(n = 1,939) 

(specificity)

Known properties 

(positive, 

negative, or 

seroconversion)

Panels known 

status.

Blood donors and 

diagnostic 

population RNA 

test, with 

AmpliCore HIV-1 

Monitor RNA test, 

Lav Blot I or 

Lav Blot II for 

confirmation

No Not reported, but 

all authors 

affiliated with 

Abbott
332

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

COBAS Core 

HIV Combo 

EIA

Weber et 

al.170

2002 >10 countries, 

including 

Cameroon, 

Germany, 

Luxembourg, 

Belgium, 

Portugal, 

Switzerland, 

South Africa, 

Thailand, and 

Zimbabwe

Commercial

seroconversion panels 

(94 panels, 709 sera)

Assessed together for 

specificity: blood 

donor samples

(n = 7,579), daily 

routine samples 

(n = 303), samples 

from hospitalized 

patients (n=997), 

potentially interfering 

samples (n = 1,222)

Assessed together for 

sensitivity: acute 

positives (n = 32), 

HIV-1 positive 

(n = 620), HIV-1 

subtyped (n = 462), 

HIV-2 positive 

(n = 462), HIV p24 

Ag/Ab positive 

(n = 120), commercial 

performance panel 

(n = 102)

For known status 

(positive, 

negative, 

seroconversion) 

or variations of 

positive types 

(at left)

Seroconversion 

panels known 

status

Negative with 

respect to 

alternate 

screening assays 

or negative WB, 

or WB 

indeterminate and 

p24 Ag negative

Positives 

confirmed by WB

No Roche 

Diagnostics 

provided 

reagents, 

analyzers, and 

financial support 

for testing WB 

and confirmation 

assays

Coulter HIV-1 

p24 Ag Assay

Willoughby 

et al.171

1989 U.S. Seropositive samples 

(from 34 individuals)

For 

seroconversion

Known status No National Institutes 

of Health 
333

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

Genscreen 

plus HIV 

Ag/Ab

Aghokeng et 

al.131

2004 Cameroon Blood donors

(n = 503)

Prevalence: 

56% confirmed 

positive

Unclear whether 

samples were 

selected for any 

particular 

characteristic but 

HIV prevalence 

was high 

(56% confirmed)

Intended to 

represent group M 

genetic diversity

Specificity

determined with 

reference to 

8 other tests:

4 rapid assays,

Enzygnost HIV 

Integral, 

Wellcozyme HIV 

Recombinant, 

HIV Blot 2.2, 

INNO-LIA. 

Positives 

confirmed with 

Inno-Lia HIV 

Confirmation or 

HIV Blot 2.2 

No National French 

agency for AIDS 

research
334

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

Saville et 

al.161

2001 US, Trinidad, the 

Bahamas, 

Cote d'Ivorie, 

Cameroon

Mixed set comprised 

of U.S. diagnostic 

samples (n = 503)

U.S. blood donors 

(n = 1,010)

High-incidence 

population in Trinidad 

(n = 1,141)

STD clinic attendees 

in Bahamas (N = 83)

Confirmed HIV-1 

group 0 from 

Cameroon (n = 10)

Confirmed HIV-2 

(n = 16)

Commercial panels:

1 panel HIV-1 group 

M antigen reactive 

(n = 9)

Prevalence (without 

seroconversion 

panel): 4.5%

Seroconversion panel 

(10 panels with 

n = 74)

Mostly unselected 

donors or patients

Archived positives

Commercially

available 

seroconversion 

panel

Known status (for 

panel and known 

samples)

Genetic Systems 

HIV-1 and HIV-2 

ELISA, or rDNA 

EIA and HIV AG1 monoclonal p24 

assay by Abbott, 

with additional 

reference tests 

WB and/or 

RT-PCR to 

investigate 

discrepancies and 

confirm positives

Yes Funded by 

bioMerieux

VIDAS HIV 

DUO ULTRA

Weber et 

al.169

2002 Commercial 

panels

Commercial 

seroconversion panels 

(16 panels)

For 

seroconversion

Known status No Roche 

Diagnostics 

provided test kits 

and financial 

support
335

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

Murex HIV 

Ag/Ab 

Combo, 

VIDAS HIV 

DUO ULTRA, 

prototype 

AxSYM HIV 

Ag/Ab combo

Ly et al.158 2001 Commercial 

panels

Seroconversion 

panels (19 panels)

For 

seroconversion

Known samples No Not reported, but 

most co-authors 

employed at 

Abbot 

Laboratories

Vironostika 

HIV Uni-Form 

II Ag/AB

Aboud et 

al.130

2006 Tanzania Submitted for 

diagnostic HIV testing 

(n = 361) or antenatal 

testing (n = 511) in 

hospital lab, or 

by blood donors

(n = 508)

Prevalence: 

22% overall confirmed

Not reported, 

appears to be all 

samples from 

sources

For negative, 

other tests: 

Enzygnost 

anti-HIV 1/2 Plus

Vironostika HIV 

Uni-Form II plus 

O

Murex HIV 

antigen/antibody.

To confirm 

positives Inno-Lia 

antibody assay. 

For 

discrepancies, 

Innotest p24 Ag 

assay.

No Financial support 

from Swedish 

International 

Development 

Agency (SIDA), 

Department of 

Research 

Cooperation

Some materials 

provided by tests 

manufacturers

Iqbal et al.143 2005 India Clinical samples from 

AIDS counseling 

center (n = 264)

Prevalence: 48%

Clinical samples 

unselected

Western Blot Blinded to 

patient 

infection status

None reported
336

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

Ly et al.157 2001 Commercial 

panels

Seroconversion 

panels, commercial 

(30 panels, 

175 samples)

Selected for 

defined properties 

(seroconversion)

Known status No None reported, 

but 

manufacturers 

supplied panels 

and kits

Seyoum et 

al.162

2005 Ethiopia

(n = 408)

Blood donors

Prevalence: 3.4%

Unselected Amplicor DNA 

PCR

ExaVir Load Test 

for HIV reverse 

transcriptase (v.2)

Amplicor HIV-1 

RNA test for 

discrepancies, or 

other antibody 

tests

No Collaboration of 

several public 

health services, 

Red Cross, and a 

University 

department

Van 

Binsbergen 

et al.165

1998 Commercial 

panels

Commercial 

seroconversion panels 

(7 panels, 

41 samples)

Selected for 

defined properties 

(seroconversion)

Known status No None reported. 

All but one author 

affiliated with 

Organon-Teknika 

(manufacturer at 

time of 

publication)

Van 

Binsbergen 

et al.166

1999 Commercial Seroconversion 

panels (10 panels)

For 

seroconversion

Known samples No Not reported, but 

all authors 

affiliated with 

Organon-Teknika 

(manufacturer 

at time of 

publication)
337

Virus/ Test 

Type Index Test(s) Citation Year

National Origin 

of Included 

Samples

Source(s) of 

Included Samples

How Selected

(Enrollment)

Reference 

Standard(s)

Blinding 

(Masking) 

Clearly Stated Funding Source

HCV 

4th generation

EIA

Monolisa 

HCV Ag/Ab 

Ultra

Laperche et 

al.151

2005 France Blood donors (n = 12), 

Hemodialysis patients 

(n = 23)

Selected for 

defined properties 

(all in 

seroconversion)

Known status

(Based upon tests 

and follow-up)

No Not reported. 

All authors 

appear to be 

affiliated with 

public sources in 

France.

COBAS 

AmpliScreen 

HCV v. 2.0

Monolisa 

HCV Ag/Ab 

Ultra

Laperche et 

al.150

2005 Commercial 

seroconversion 

panels from U.S. 

companies

Commercial 

seroconversion panels 

(10 panels, 

107 samples)

For 

seroconversion

Known status No Not reported, 

appears to be 

French public 

source
338

Analysis Methods

The characteristics of interest for this question are turnaround time, window period, and diagnostic 

performance. The methods used to assess each of these outcomes differ. The following paragraphs define 

those characteristics and explain the procedures used to collect information regarding them. In data 

extraction tables, data are presented separately for each test because results may vary by test, even within 

the same generation.

Turnaround Time

Turnaround time is the duration of time required for a sample to be fully assessed. As this information 

was sparsely reported in clinical literature, we also extracted relevant data from other sources, particularly 

review articles and grey literature including primary technology assessments and package insert 

information. Where no other data were available we also extracted similar information such as “run time.” 

Note that “run time” is only the analytic component of turnaround time and does not include time needed 

for specimen preparation and ost-analytic reporting time. These instances are clearly noted in the data 

tables.

Window Period

Window period refers to the duration of time between infection and test positivity. The information 

regarding window periods comes from using the test of interest on seroconversion panels. Seroconversion 

panels are series of blood draws from patients who eventually become seropositive. They are typically 

collected from people at high risk for infection. Although a few investigators studied their own in-house 

seroconversion panels, most such panels were purchased from laboratory supply companies. These tests 

enable estimation of time to positive test result from first blood collection. However, the first day of blood 

collection may not coincide with the day of infection. Also, these samples are typically collected at 

irregular intervals, not daily. These limitations cloud the estimation of the period of time between 

infection and when the test detects infection. Studies generally reported the difference in window period 

between two tests (e.g., Test 2 detected infection an average of 5 days later than Test 1). This type of 

information comprises the information in the results section on window period. No information was 

identified that captured absolute window periods using actual samples.

Diagnostic Performance

The most commonly used study design to evaluate the accuracy of a diagnostic test is the diagnostic 

cohort study, in which all enrolled patients are examined with both the diagnostic test of interest and the 

accepted reference standard test. “Accuracy” is defined as the proportion of times the test of interest 

correctly categorizes an individual as having disease or not. The accepted reference standard test 

accurately categorizes the patient as having infection or not. (A reference standard capable of determining 

the true infection status of the patient is sometimes referred to as the “gold standard.”) The accuracy of 

the test of interest is determined with reference to the infection status of the patient, as determined by the 

reference standard, as shown in Table 48. The information in this table can be used to calculate sensitivity 

and specificity of the test of interest, and where the prevalence of disease in the tested data set is similar 

to the prevalence in the target population, can be used to determine predictive values and likelihood ratios 

(these terms are defined in the text following the table).
339

Table 48. Determining Diagnostic Performance

True Status (Reference Standard)

Infected Not Infected

Test of interest Positive True Positive False Positive

Negative False Negative True Negative

However, because there are no perfect tests for the diagnosis of HBV, HCV, or HIV, no true single gold 

standard test currently exists. True disease state would be most accurately determined using information 

from more than one source (e.g., confirmatory tests, clinical assessment), possibly with repeat testing at a 

follow-up time to confirm negatives (after a window period has passed). However, for the purposes of 

identifying as much information as possible for inclusion in this report, data were collected without regard 

to the accuracy of the reference standard (although studies that employ poor reference standards will be 

downgraded for study design and quality). It is important to bear this in mind when assessing the 

extracted data because the reference standard influences diagnostic performance data. This is particularly 

true when a more sensitive test is compared to a less sensitive test. For instance, if the test of interest is 

more sensitive than the reference standard and no additional discriminatory tests are performed, positives 

that the test of interest catches but the reference standard misses will be misclassified as false positives

and specificity will be underestimated. (For this reason we refer to these outcomes as measures of

“Diagnostic Performance” rather than “Diagnostic Accuracy.”) In the data extraction tables, the reference 

standard used is always presented alongside the diagnostic performance data. Where more than one set of 

information is reported for a particular test of interest, greatest heed should be paid to the statistic 

determined using the most accurate reference standard(s).

Commonly used diagnostic performance measures are calculated from the type of information provided in 

Table 48 and include sensitivity and specificity, predictive values, and likelihood ratios. Sensitivity is the 

proportion of people with the infection (as determined by the reference standard) that the test of interest 

correctly recognizes as positive. A test with high sensitivity will rarely misclassify people with the disease 

as not having the disease (the test has a low rate of false-negatives). Specificity is the proportion of people 

without infection (as determined by the reference standard) that the test of interest correctly recognizes as 

negative. A test with high specificity will rarely misclassify people without the disease as diseased (it has 

a low rate of false-positives). Sensitivity and specificity are both expressed on a scale of 0% to 100%, 

with greater values showing more agreement between the test of interest and the reference standard, and a 

value of 50% being correct as frequently as random guessing. However, knowing the sensitivity and 

specificity of a test does not tell you whether a particular patient with a positive or negative test is 

infected or not.

Other measures of diagnostic performance are more clinically applicable. The positive predictive value 

(PPV) of a test is the probability of a patient having the disease following a positive test result. The 

negative predictive value (NPV) is the probability of a patient not having the disease following a negative 

test result. Likelihood ratios indicate how much more likely patients with the disease are to have that 

particular result than patients without the disease. Positive likelihood ratios (PLR) indicate how much 

more likely people with infection are to have a positive test result, and negative likelihood ratios (NLR) 
340

indicate how much more people with infection are to have a negative result. Values of greater than one 

suggest infection, and values of less than one suggest not having infection. Unlike sensitivity and 

specificity, predictive values and likelihood ratios are influenced by the prevalence of the disease in the 

population of patients being tested. For this reason, we did not report (or calculate) predictive values or 

likelihood ratios from data not applicable to potential organ donors.

Diagnostic performance measures typically involve a trade-off between counterpart metrics. For instance, 

increasing sensitivity (catching more of the true positives) may be at the expense of decreasing specificity 

(more false positives too). Acceptable thresholds for diagnostic performance and trade-off between 

sensitivity and specificity will vary by intended use of the test.

Assessment of Peer-reviewed Studies

We assessed the design and risk of bias (quality) of the peer-reviewed studies and rated the strength of the 

evidence using guidelines proposed by the GRADE working group (Schunemann et al. (2008)2

; also 

available online through links found at the GRADE Web site.) We assessed studies reporting diagnostic 

characteristics using these protocols. It is likely that there is an interaction between study design and 

study limitations/risk of bias, with the lower-rated studies providing less reliable results. Where multiple 

studies report data on the same test, the study or studies with the fewest detractions on quality should be 

considered more reliable. 

We did not assess turnaround time because most of that information was not evidence-based. We did not 

assess window period in this manner either, because much of the information came from sources other 

than peer-reviewed publications and insufficient information was reported to assess them in full, and 

because there was no information directly pertinent to absolute window period.

Study Design

According to the GRADE diagnostics rating guidance, study design should initially be considered “high” 

quality if the study assesses patients with diagnostic uncertainty (e.g., unknown infection status) and 

comparison of results of test of interest with an appropriate reference standard.2 The following paragraphs 

describe the standards we used to determine appropriateness of reference standard and diagnostic 

uncertainty. Studies that fulfilled both of these criteria were initially rated as “high.” Studies that fulfilled 

only one were initially rated as “moderate.” For evidence bases comprised of more than one study, we 

used the median number of items to determine the overall initial GRADE rating. Individual study design 

factors are itemized in Table 49.

Reference Standard

As described in the Methods section, the correctness of the reference standard in deeming whether or not 

the sample is infected influences the diagnostic characteristics reported in that study, because all 

characteristics are calculated with reference to that standard. When a reference standard mis-categorizes 

the true status of samples, correct identification of samples by the test of interest will be considered 

wrong. An example of a test that is not reasonable could be an earlier generation of the test of interest. 

Because a first-generation EIA should be less sensitive than a third generation test, it is an inappropriate 

reference standard and will lead to positive samples identified by the more sensitive 3rd generation that 

were not recognized by the older test being misclassified as false positives rather than true positives. If the 

older test has more frequent false positives, the sensitivity of the newer test will be underestimated. 
341

Although another EIA may be an appropriate reference standard for specificity (to confirm negatives), a

NAT or Western blot (WB) would have been more appropriate reference standards for sensitivity (to 

confirm positives) or to resolve discrepancies between the EIAs. However, because no single test is 

always correct, the most accurate way to determine the true status of the sample is to use multiple testing 

methods, including using additional tests to resolve discrepant findings between the test of interest and 

the reference test, and to confirm positives. Clinical information could also contribute to the definitive 

status. In addition, to determine whether either the reference test or the test of interest may have both 

misclassified an infected sample as negative, samples should be drawn again after completion of a 

window period. Such practices could provide a very convincing and definitive reference standard by 

which to judge the characteristics of the test of interest. Well-characterized commercially purchased 

samples (such as from a laboratory supply company) should also provide a very accurate reference 

standards. Commercial samples are typically characterized using a variety of tests, including confirmatory 

tests and quantitative tests for positive samples.

Diagnostic Uncertainty

Diagnostic uncertainty pertains to whether the infection status of a sample is known before study 

enrollment. Selecting individuals based upon their infection status is likely to cause spectrum bias. 

Spectrum bias is mostly an issue of external validity; however, it may also bias diagnostic performance 

characteristics. If only patients who are either infected or uninfected are selected for inclusion, the study 

results generally suggest the test is more accurate than it really is. Spectrum bias would be best controlled 

for by enrolling an unselected (preferably consecutive or random) group of potential organ donors. Other 

unselected populations, such as general populations or blood donors, may provide reasonable substitutes, 

although these populations may differ in unknown way from potential organ donors (the characteristics of 

whom have been poorly described), including prevalence of infection and severity of disease. When test 

performance is measured within a cohort of individuals with unknown disease status representative of the 

target population, the study is assessing “clinical” performance. Such studies minimize the potential 

influence of spectrum bias and provide the best approximation of real-world use.

Studies that only assessed sensitivity or specificity (or only positive or negative likelihood ratios or 

predictive values) were excluded from the evidence base. We included studies that reported both 

sensitivity and specificity with the intent of assessing both counterpart statistics derived from testing the 

same set of samples, to assess “clinical” diagnostic performance. However, some studies assessed 

sensitivity in known infected samples only and specificity in known uninfected samples only. 

Characterized infected and uninfected samples were purchased from laboratory supply companies or 

retrieved from laboratory archives. This type of a study is assessing “analytic” performance. Such studies 

may not accurately represent the performance of the test in real-world use (typically, overestimation can 

be expected) and are ripe for spectrum bias. They may also be susceptible to further potential bias if no 

blinding occurs, especially if investigators have a vested interest in any particular test(s). Because the true 

status of the samples is already known, these analytic studies have some of the same limitations as other 

retrospective studies.
342

Table 49. Study Design Items for Diagnostic Performance

Virus/ Test 

Type

Test Trade Name Manufacturer Cite Study Design Factor 

Satisfied

Individual 

Study Design 

Rating

GRADE Study 

Design 

Starting Point 

for Test Reference 

Standard

Diagnostic 

Uncertainty

Tests currently in use in U.S. Organ Procurement Organization (OPO): Immunoassays

HIV

3rd generation 

EIA

Genetics System (GS) HIV-1/HIV-2 Plus 0 EIA Bio-Rad 

Laboratories

Owen et al. 

2008159

 - Moderate Moderate

HIVAB HIV-1/HIV-2 (rDNA) EIA Abbott Laboratories Barbe et al. 

1994134

 - Moderate Moderate

Owen et al. 

2008159

 - Moderate

HBV (HBsAg; 

the surface 

antigen)

Abbott AxSYM HBsAg Assay Abbott Laboratories Diepersloot et al. 

2000140

  High High

Abbott PRISM HBsAg Abbott Laboratories No studies - - - -

ADVIA Centaur HBsAg Assay Siemens Healthcare 

Diagnostics

Huzly et al. 

2008142

 - Moderate Moderate

Genetic Systems (GS) HBsAg EIA 3.0 Bio-Rad 

Laboratories

No studies - - - -

HBV (anti-HBs; 

antibodies to 

the surface 

antigen)

Ortho Antibody to HBsAg ELISA Test System 3 Ortho Clinical 

Diagnostics

No studies - - - -

HBV (anti-HBc; 

antibodies to 

the core 

antigen)

Abbott PRISM HBcore Abbott Laboratories No studies - - - -

ADVIA Centaur HBc Total Assay Siemens Healthcare 

Diagnostics

No studies - - - -
343

Virus/ Test 

Type

Test Trade Name Manufacturer Cite Study Design Factor 

Satisfied

Individual 

Study Design 

Rating

GRADE Study 

Design 

Starting Point 

for Test Reference 

Standard

Diagnostic 

Uncertainty

AxSYM Core 2.0 Abbott Laboratories No studies - - - -

CORZYME Abbott Laboratories No studies - - - -

Ortho HBc ELISA Test System Ortho Clinical 

Diagnostics

No studies - - - -

HCV Abbott HCV EIA 2.0 Abbott Laboratories Anderson et al. 

1995132

-  Moderate High

Laycock et al. 

1997152

  High

Leon et al. 

1993153

  High

ADVIA Centaur HCV assay Siemens Healthcare 

Diagnostics

Denoyel et al. 

2004139

 - Moderate High

Kita et al. 

2009146

  High

AxSYM Anti-HCV Abbott Laboratories No studies - - - -

Ortho HCV Version 3.0 ELISA Test System Ortho Clinical 

Diagnostics

Kita et al. 

2009146

  High High

Vrielink et al. 

1995167

  High

Vrielink et al. 

1995168

 - Moderate
344

Virus/ Test 

Type

Test Trade Name Manufacturer Cite Study Design Factor 

Satisfied

Individual 

Study Design 

Rating

GRADE Study 

Design 

Starting Point 

for Test Reference 

Standard

Diagnostic 

Uncertainty

Tests currently in use in U.S. Organ Procurement Organization (OPO): NAT

HIV NAT COBAS AmpliScreen HIV-1 Test v. 1.5 Roche Diagnostics Bamaga et al. 

2006133

-  Moderate Moderate

Owen et al. 

2008159

 - Moderate

HCV NAT COBAS AmpliScreen HCV Test version. 2.0 Roche Diagnostics Bamaga et al. 

2006133

-  Moderate Moderate

HBV NAT COBAS AmpliScreen HBV Test Roche Diagnostics Kleinman et al. 

2005147

  High High

HCV and HIV-1 

NAT

ProCleix HIV-1/HCV Assay Gen-Probe 

Incorporated

Jackson et al. 

2002144 – HIV

  High Moderate

Vargo et al. 

2002128 – HIV 

 - Moderate

Jackson et al. 

2002144 – HCV

  High

Vargo et al. 

2002128 – HCV

 - Moderate

Vargo et al. 

2002128 –

Co-infected

 - Moderate
345

Virus/ Test 

Type

Test Trade Name Manufacturer Cite Study Design Factor 

Satisfied

Individual 

Study Design 

Rating

GRADE Study 

Design 

Starting Point 

for Test Reference 

Standard

Diagnostic 

Uncertainty

Tests not in use in U.S. Organ Procurement Organization (OPO): 4th generation Ag/Ab Immunoassays

HIV 

4th generation

ARCHITECT HIV Combo Abbott Laboratories Kwon et al. 

2006149

 - Moderate Moderate

Ly et al. 

2007154

 - Moderate

AxSYM HIV Ag/Ab Combo Abbott Laboratories Bourlet et al. 

2005136

  High Moderate

Kwon et al. 

2006149

 - Moderate

Ly et al. 2007156  - Moderate

Sickinger et al. 

2007163

 - Moderate

COBAS Core HIV Combi Roche Diagnostics Ly et al. 

2007154

 - Moderate Moderate

Weber et al. 

2002170

 - Moderate

Coulter HIV-1 p24 Antigen Assay Coulter Corporation No studies - - - -

Enzygnost HIV Integral II Siemens Healthcare 

Diagnostics

No studies - - - -

Genscreen Plus HIV Ag/Ab Combo Bio-Rad 

Laboratories

Aghokeng et al. 

2004131

  High High

Ly et al. 

2007156

 - Moderate

Genscreen HIV Ultra Ag-Ab Assay Bio-Rad 

Laboratories

Ly et al. 

2007154

 - Moderate Moderate
346

Virus/ Test 

Type

Test Trade Name Manufacturer Cite Study Design Factor 

Satisfied

Individual 

Study Design 

Rating

GRADE Study 

Design 

Starting Point 

for Test Reference 

Standard

Diagnostic 

Uncertainty

Modular HIV Combi Roche Diagnostics No studies - - - -

Murex HIV Ag/Ab Combo Abbott Laboratories Ly et al. 

2007156

 - Moderate Moderate

VIDAS DUO QUICK bioMerieux Clinical 

Diagnostics

No studies - - - -

VIDAS DUO ULTRA bioMerieux Clinical 

Diagnostics

Bourlet et al. 

2005136

  High High

Ly et al. 

2007154

 - Moderate

Saville et al. 

2001161

  High

Vironostika HIV Uni-Form II Ag/Ab bioMerieux Clinical 

Diagnostics

Aboud et al. 

2006130

  High High

Iqbal et al. 

2005143*

  High

Ly et al. 

2007156

 - Moderate

Seyoum et al. 

2005162

  High

HCV

4th generation

INNOTEST HCV Ab IV Innogenetics NV No studies - - - -

Monolisa HCV Ag/Ab Ultra Bio-Rad 

Laboratories

No studies - - - -

Murex 4.0 Abbott Laboratories No studies - - - -

* Iqbal et al. reported outcomes for two data sets, which are both shown in Table 56. However, for the purposes of assessment of the evidence base (to eliminate double-influence of one study on the overall 

rating), the diagnostic data set is represented here.
347

Limitations (Risk of Bias/Quality)

In addition to study design, we assessed the limitations of each study using three more items. To assess 

the limitations of the included studies that report diagnostic performance outcomes, we asked the 

following three questions:

• Enrollment: Was there enrollment of consecutive/all, or random sample, of eligible patients?

• Data loss: Is data loss minimal?

• Blinding: Was blinding performed for both the test of interest and the reference standard?

Failure to apply a reference standard to all samples was basis for exclusion (e.g., if all negatives were 

assumed to be true negatives), so we did not assess that factor.

The following paragraphs describe the criteria used to determine whether a particular study had a 

limitation. Itemized limitation assessment for all included studies is provided in Table 50. Studies with 

one or more limitations are detracted one point in GRADE. If the majority of studies in a multiple-study 

evidence base have one or more limitations, the strength is likewise detracted one point in GRADE. 

Following these paragraphs, itemized assessment for each study is provided in Table 50.

Enrollment

Enrollment of all eligible patients, a consecutive series of patients, or a random selection of patients or 

blood samples minimizes the threat of sampling bias. Samples that are “unselected” with unknown status 

also satisfy this criterion. Selecting panels for a particular characteristic (i.e., known infected or known 

uninfected) does not satisfy this item regardless of the method used to select them because such sample 

sets are highly selected and prone to selection bias.

Data Loss

Although there may be no attrition in diagnostic cohort studies, data may be excluded from the evidence 

base when the true status of the sample is inconclusive. Ideally, researchers would deal with conflicting or 

inconclusive test results by performing additional tests on the sample. Samples that remain inconclusive 

may have low antibody titers or amounts of nucleic acid and were possibly collected during a window 

period. Re-testing at a later date (to allow for a window period to pass) could help to establish definitive 

status. Rather than perform these additional tests to reconcile conflicting results with true status, some 

studies simply exclude the inconclusive samples from the data set. Data may also be excluded if there are 

errors in collecting the samples or performing the test. If enough data sets are excluded to impact the 

outcome statistics, diagnostic performance is likely to be overestimated. We considered this criterion not 

satisfied if more than 5% of data are lost due to any cause.

Blinding

Blinding is a commonly recognized way to protect against diagnostic bias when interpreting results. 

Although qualitative assessment of a sample should require little interpretation, lack of blinding could 

lead to miscategorization. Knowing the sample status could lead to misclassification of incorrect results 

as inconclusive (possibly resulting in the exclusion of that sample), especially if the result is close to the 

threshold or if it leads the researcher to recognize an error was made. This could be a particular problem 

if the investigator has a potential conflict of interest with the study findings.
348

Table 50. Quality Assessment of Question 5: Diagnostic Characteristics

Virus/ Test 

Type

Test Trade Name Manufacturer Cite Limitation Item Met Number of 

Items Satisfied

Starting Grade 

Adjustment for 

Quality Enrollment Data Loss 

(Excessive 

Exclusions)

Blinding

Tests currently in use in U.S. Organ Procurement Organization (OPO): Immunoassays

HIV

3rd generation 

EIA

Genetics System (GS) 

HIV-1/HIV-2 Plus 0 EIA

Bio-Rad 

Laboratories

Owen et al. 

2008159

  - 2 -1

HIVAB HIV-1/HIV-2 (rDNA) 

EIA

Abbott 

Laboratories

Barbe et al. 

1994134

  - 2

-1

Owen et al. 

2008159

  - 2

HBV (HBsAg; 

the surface 

antigen)

Abbott AxSYM HBsAg

Assay

Abbott 

Laboratories

Diepersloot et al. 

2000140

  - 2 -1

Abbott PRISM HBsAg Abbott 

Laboratories

No studies - - - - -

ADVIA Centaur HBsAg 

Assay

Siemens 

Healthcare 

Diagnostics

Huzly et al. 

2008142

  - 2 -1

Genetic Systems (GS) 

HBsAg EIA 3.0

Bio-Rad 

Laboratories

No studies - - - - -

HBV (anti-HBs; 

antibodies to the 

surface antigen)

Ortho Antibody to HBsAg 

ELISA Test System 3

Ortho Clinical 

Diagnostics

No studies - - - - -

HBV (anti-HBc; 

antibodies to the 

core antigen)

Abbott PRISM HBcore Abbott 

Laboratories

No studies - - - - -

ADVIA Centaur HBc Total 

Assay

Siemens 

Healthcare 

Diagnostics

No studies - - - - -
349

Virus/ Test 

Type

Test Trade Name Manufacturer Cite Limitation Item Met Number of 

Items Satisfied

Starting Grade 

Adjustment for 

Quality Enrollment Data Loss 

(Excessive 

Exclusions)

Blinding

AxSYM Core 2.0 Abbott 

Laboratories

No studies - - - - -

CORZYME Abbott 

Laboratories

No studies - - - - -

Ortho HBc ELISA Test 

System

Ortho Clinical 

Diagnostics

No studies - - - - -

HCV Abbott HCV EIA 2.0 Abbott 

Laboratories

Anderson et al. 

1995132

  - 2

-1 Laycock et al. 

1997152

  - 2

Leon et al. 

1993153

  - 2

ADVIA Centaur HCV assay Siemens 

Healthcare 

Diagnostics

Denoyel et al. 

2004139

-  - 1

-1

Kita et al. 

2009146

  - 2

AxSYM Anti-HCV Abbott 

Laboratories

No studies - - - - -

Ortho HCV Version 3.0 

ELISA Test System

Ortho Clinical 

Diagnostics

Kita et al. 

2009146

  - 2

-1 Vrielink et al. 

1995167

  - 2

Vrielink et al. 

1995168

-  - 1
350

Virus/ Test 

Type

Test Trade Name Manufacturer Cite Limitation Item Met Number of 

Items Satisfied

Starting Grade 

Adjustment for 

Quality Enrollment Data Loss 

(Excessive 

Exclusions)

Blinding

Tests currently in use in U.S. Organ Procurement Organization (OPO): NAT

HIV NAT COBAS AmpliScreen HIV-1 

Test v. 1.5

Roche 

Diagnostics

Bamaga et al. 

2006133

  - 2

-1

Owen et al. 

2008159

  - 2

HCV NAT COBAS AmpliScreen HCV 

Test version. 2.0

Roche 

Diagnostics

Bamaga et al. 

2006133

  - 2 -1

HBV NAT COBAS AmpliScreen HBV 

Test

Roche 

Diagnostics

Kleinman et al. 

2005147

  - 2 -1

HCV and HIV-1 

NAT

ProCleix HIV-1/HCV Assay Gen-Probe 

Incorporated

Jackson et al. 

2002144 – HIV

  - 2

0

Vargo et al. 

2002128 – HIV 

   3

Jackson et al. 

2002144 – HCV

  - 2

Vargo et al. 

2002128 – HCV

   3

Vargo et al. 

2002128 –

Co-infected

   3
351

Virus/ Test 

Type

Test Trade Name Manufacturer Cite Limitation Item Met Number of 

Items Satisfied

Starting Grade 

Adjustment for 

Quality Enrollment Data Loss 

(Excessive 

Exclusions)

Blinding

Tests not in use in U.S. Organ Procurement Organization (OPO): 4th generation Ag/Ab Immunoassays

HIV 

4th generation

ARCHITECT HIV Combo Abbott 

Laboratories

Kwon et al. 

2006149

-  - 1

-1

Ly et al. 

2007154

-  - 1

AxSYM HIV Ag/Ab Combo Abbott 

Laboratories

Bourlet et al. 

2005136

  - 2 -1

Kwon et al. 

2006149

-  - 1

Ly et al. 

2007156

-  - 1

Sickinger et al. 

2007163

-  - 1

COBAS Core HIV Combi Roche 

Diagnostics

Ly et al. 

2007154

-  - 1 -1

Weber et al. 

2002170

-  - 1

Coulter HIV-1 p24 Antigen 

Assay

Coulter 

Corporation

No studies - - - - -

Enzygnost HIV Integral II Siemens 

Healthcare 

Diagnostics

No studies - - - - -
352

Virus/ Test 

Type

Test Trade Name Manufacturer Cite Limitation Item Met Number of 

Items Satisfied

Starting Grade 

Adjustment for 

Quality Enrollment Data Loss 

(Excessive 

Exclusions)

Blinding

Genscreen Plus HIV Ag/Ab 

Combo

Bio-Rad 

Laboratories

Aghokeng et al. 

2004131

  - 2 -1

Ly et al. 

2007156

-  - 1

Genscreen HIV Ultra Ag-Ab 

Assay

Bio-Rad 

Laboratories

Ly et al. 

2007154

-  - 1 -1

Modular HIV Combi Roche 

Diagnostics

No studies - - - - -

Murex HIV Ag/Ab Combo Abbott 

Laboratories

Ly et al. 

2007156

-  - 1 -1

VIDAS DUO QUICK bioMerieux 

Clinical 

Diagnostics

No studies - - - - -

VIDAS DUO ULTRA bioMerieux 

Clinical 

Diagnostics

Bourlet et al. 

2005136

  - 2 -1

Ly et al. 

2007154

-  - 1

Saville et al. 

2001161

   3

Vironostika HIV Uni-Form II 

Ag/Ab

bioMerieux 

Clinical 

Diagnostics

Aboud et al. 

2006130

  - 2 -1

Iqbal et al. 

2005143*

  - 2

Ly et al. 

2007156

-  - 1
353

Virus/ Test 

Type

Test Trade Name Manufacturer Cite Limitation Item Met Number of 

Items Satisfied

Starting Grade 

Adjustment for 

Quality Enrollment Data Loss 

(Excessive 

Exclusions)

Blinding

Seyoum et al. 

2005162

  - 2

HCV

4th generation

INNOTEST HCV Ab IV Innogenetics NV No studies - - - - -

Monolisa HCV Ag/Ab Ultra Bio-Rad 

Laboratories

No studies - - - - -

Murex 4.0 Abbott 

Laboratories

No studies - - - - -

* Iqbal et al. reported outcomes for two data sets, which are both shown in Table 55. However, for the purposes of assessment of the evidence base (to eliminate double-influence of one study on the overall rating), 

the diagnostic data set is represented here.
354

Additional Considerations

Consistency

Although in some instances several studies addressed the same test of interest, different reference 

standards and samples were used. Differences in these two fundamental study design factors can be 

expected to lead to differences in outcomes and to dictate generalizability. In this respect, each study 

should probably best be considered in isolation. For this reason we did not downgrade for inconsistency, 

although we do summarize multiple studies to provide an overall picture of the tests’ performances.

Directness

In the assessment of diagnostic technologies, GRADE assessment of directness pertains to whether direct 

measures of diagnostic performance (e.g., patient-oriented clinical outcome) or indirect measures of 

diagnostic performance (e.g., intermediate or surrogate outcomes such as sensitivity and specificity) are 

reported. In this assessment, all data were indirect. However, the purpose of the question was to assess 

“test characteristics,” specifically including sensitivity and specificity. Detracting points because the 

study addresses the question of interest is inappropriate; therefore, we did not.

Precision

Lack of precision is typically measured by 95% confidence intervals (CI) of outcome statistics. Because 

not all studies reported CI or data necessary to calculate CI, we considered the factor that influences 

precision instead, number of samples assessed. As most of the sample sets assessed were large (only four 

had 200 or fewer samples) and the smaller evidence bases had an over-representation of infection 

compared with real-world prevalence, we did not detract for precision.

Publication Bias

Because traditional methods of publication bias assessment are not useful for small evidence bases and 

evidence bases for which quantitative assessment is inappropriate, such as those addressing each test of 

interest, we assessed the potential for publication bias by considering whether at least half of the studies 

for a particular test were funded by the test’s manufacturer. If studies with significant findings are more 

likely to be published, and if only manufacturers funded the published studies, it is possible that 

independently funded studies with non-significant findings were never published. The main limitation of 

this method is that most of the studies did not report a funding source. 

Full GRADE assessments are shown in Table 56, after the Results section and tables.

Results

Although a large number of peer-reviewed publications and pieces of gray literature were included, little 

(or no) data addressed each of the individual studies of interest. Only one study may have collected 

samples from deceased individuals (corneal donors). None of the studies appear to have focused on 

pediatric use. Due to this, it was not possible to determine differential test performance among 

populations or by donor clinical status.

The following sections provide summaries of results. Full results data are provided in the tables following 

these sections.
355

Turnaround Time

Information on the time required to fully administer diagnostic tests was sparse. For most of the test 

categories, no data were identified, despite consulting multiple sources for data. Available turnaround 

times are summarized by test type in Table 51. Full data extraction on turnaround time on a per-test basis 

is shown in Table 4.

Table 51. Summary of Turnaround Times

Test Category Turnaround Time

Tests currently in use in U.S. Organ Procurement Organizations (OPO): Immunoassays

HIV, 3rd generation EIA No data

HBsAg EIA 29 minutes for Advia Centaur (not reported for any of the others)

Anti-HBs EIA No data

Anti-HBc EIA No data

HCV, 2nd or 3rd generation EIA No data

Tests currently in use in U.S. Organ Procurement Organizations (OPO): NAT

HIV NAT 2 hours

HCV NAT 2 hours

HBV NAT No data

HCV and HIV-1 NAT Combined 6 hours

Tests not in use by U.S. Organ Procurement Organizations (OPO): 4th generation Ag/Ab Immunoassays

HIV 4th generation Ag/Ab EIA 26 minutes to 4 hours, depending on test brand

HCV 4th generation Ag/Ab EIA 190 minutes for one test brand
356

Window Period

Due to the limitations of using seroconversion panels to attempt to determine absolute window periods 

(previously defined as the duration between being infected and testing positive), we summarized the 

window periods relative to other tests. We report mean differences in time to detection among tests, and 

where reported, the range of time to detection. “Mean range” refers to the range of means when more than 

one study reported this data. These data were extracted from peer-reviewed publications and gray 

literature including independent laboratory assessments and product labeling information. 

This information is presented in Table 52. Full data extraction on window periods and additional related 

information on a per-test basis is shown in Table 4.

Table 52. Summary of Window Periods and Related Data

Test Category Window Period

Tests currently in use in U.S. Organ Procurement Organizations (OPO): Immunoassays

HIV, 3rd generation EIA Positive mean 12-14 days before Western blot, but in one panel at the same time 

as Western blot

HBsAg EIA Positive range of 0-7 days before other unnamed licensed test

Anti-HBs EIA Positive range of 14-18 days after NAT

Positive later than HBsAg EIA on some samples

Anti-HBc EIA Positive 1-4 weeks after HBsAg, coincident with symptom onset

HCV, 2nd or 3rd generation EIA Positive mean of 30-35 days after RNA test, and overall range of time to detect 

infection 4-118 days 

Tests currently in use in U.S. Organ Procurement Organizations (OPO): NAT

HIV NAT* Positive range of 2-15 days before Ab test

Positive range 7-10 days before p24 Ag test

Positive range of 0-28 days before Ag test alone

HCV NAT* Positive mean range of 25-85 days (and where reported absolute range 5-186 

days) before confirmed 3rd generation Ab test (and a mean of 113 days before 

2nd generation Ab test)

Positive mean 5 days (range: 0-24 days) before 4th generation test 

HBV NAT Positive mean range 10 to 15 days (overall range where reported 4-18 days) 

before HBsAg (single-sample procedure)

Tests not in use by U.S. Organ Procurement Organizations (OPO): 4th generation Ag/Ab Immunoassays

HIV 4th generation Ag/Ab EIA Positive means of 1.4 to 2 days after PCR

Positive means of 1.5 to several days before 3rd generation

HCV 4th generation Ag/Ab EIA Positive mean of 5 days (range: 0-24 days) after NAT, a mean of 4.8 days 

(range: 0-32 days) after PCR, and a mean of 30 days after RNA assay

Positive mean of 26 days (range: 0-72 days) before 3rd generation

*Includes data from combined HIV/HCV NAT
357

Diagnostic Performance

All of the extracted diagnostic performance data were sensitivity and specificity, drawn from clinical and 

analytic performance studies. Predictive values and likelihood ratios from potentially generalizable 

populations were not reported. We did not calculate these values because the prevalence of infection 

among potential solid organ donors has not been clearly defined. A summary of sensitivity and specificity 

data by test category are shown in Table 53. The summarized data are point estimates. Where multiple 

estimates were reported, the lowest and highest (range of) values are reported. Full data extraction per test 

by name is shown in Table 55. 

The last column of Table 53 shows the median GRADE assessment for the evidence base for the test 

category; full GRADE assessments for each test are shown in Table 56. In brief, reasons for GRADE 

detraction most commonly included lack of blinding and lack of diagnostic uncertainty. Inappropriate 

reference standard was encountered less frequently, but could have strong effects on the outcomes (see 

HIV NAT and HCV NAT summary statistics in the table below). No studies had substantial data loss. 

Table 56 also notes whether each statistic was calculated from an analytic study or a clinical study.

Table 53. Summary of Sensitivity and Specificity Data (Range of Reported Point 

Estimates)

Test Category Sensitivity Specificity GRADE (Table 56)

Tests currently in use in U.S. Organ Procurement Organizations (OPO): Immunoassays

HIV, 3rd generation EIA 99.4% to 100% 97.7% to 99.7% Low

HBsAg EIA 100% 97.9% to 99.4% Low to Moderate

Anti-HBs EIA No data No data -

Anti-HBc EIA No data No data -

HCV, 2nd or 3rd generation EIA 73.2% to 100% 92.7% to 99.9% Moderate

Tests currently in use in U.S. Organ Procurement Organizations (OPO): NAT*

HIV NAT** 92.6% to 100% 96.9% to 100% Low 

HCV NAT** 99.3% to 99.6% 97.4% to 99.6% Low

HBV NAT 84.8% 100% Very Low

Tests not in use by U.S. Organ Procurement Organizations (OPO): 4th generation Ag/Ab Immunoassays

HIV 4th generation Ag/Ab EIA 100% (all) 82.5% to 100% (Most >99%) Low to Moderate

HCV 4th generation Ag/Ab EIA No data No data -

*Includes data from combined HIV/HCV test

**Summary table does not include data from Bamaga et al. due to lack of sufficiently accurate reference standard for determining sensitivity 

and specificity. Data from that study are shown in the evidence tables.
358

Table 54. Overview of Diagnostic Tests

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

Tests Currently in Use by U.S. Organ Procurement Organizations (OPOs): Immunoassays

HIV

3rd generation 

EIA

Genetics 

System (GS) 

HIV-1/HIV-2 

Plus 0 EIA

Bio-Rad 

Laboratories

8/5/2003 EIA Living 

(serum, 

plasma), 

Deceased 

donor 

(serum)

From 15 seroconversion panels, at least half of the results were 

positive about 14 days before Western blot.159

In the package labeling in the FDA approval document, data are 

reported on use in 50 seroconversion panels, compared with FDA 

licensed HIV-1/HIV-2 EIAs and a licensed HIV-1 Western blot. 

Compared with (unnamed) kit 1, it detected infection sooner 74% of 

the time and at the same time in the remainder. Compared with 

(unnamed) kit 2 (in only 46 of the panels), it detected HIV sooner 

18% of the time, at the same time 70% of the time, and later 12% of 

the time. Compared with the Western blot it became positive sooner 

in 74% and at the same time in 26%.195

-

HIVAB 

HIV-1/HIV-2 

(rDNA) EIA

Abbott 

Laboratories

7/22/2004 EIA Living 

(serum, 

plasma), 

Deceased 

donor 

(serum)

In 7 of 8 seroconversion panels, positive responses were obtained 

4 to >9 days sooner than Western blot, and at the same time in the 

eighth.134

From 15 seroconversion panels, at least half of the test results were 

positive about 12 days before Western blot.159

In the package insert, on 9 seroconversion panels this test detected 

antibody at the same time or sooner than the Abbott HIVAB HIV-1 

EIA (three times positive when Abbott was inconclusive, and one 

time inconclusive when Abbott was negative). In one of the panels it 

detected HIV two bleeds (8 days) before Western blot.190

-

HBV (HBsAg; 

the surface 

antigen)

Abbott 

AxSYM 

HBsAg

Assay

Abbott 

Laboratories

6/1/2006 

original 

approval; 

2/5/2007 

manufacturing 

change; 

12/19/2007 

labeling 

change

Microparticle 

EIA

Living 

(serum, 

plasma)

In its FDA Summary of Safety and Effectiveness Data and Product 

Label, AxSYM HBsAg detected infection 3 to 7 days earlier than a 

(unnamed) FDA-licensed reference in 5 out of 15 seroconversion 

panels, and on the same day in the remaining 10.194

-
359

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

Abbott 

PRISM 

HBsAg

Abbott 

Laboratories

7/18/2006 ChLIA Living 

(serum, 

plasma), 

Deceased 

donor 

(serum)

- -

ADVIA 

Centaur 

HBsAg 

Assay

Siemens 

Healthcare 

Diagnostics

5/26/2005 

original 

approval; 

3/4/2009 

process 

change

EIA Living 

(serum, 

plasma)

In the product label, in 6 seroconversion panels this test was positive 

at the same time as the (unnamed) reference assay in 5 serials, and 

two bleeds sooner in the remaining serial.189

29155 to 

30142 minutes

Genetic 

Systems 

(GS) HBsAg 

EIA 3.0

Bio-Rad 

Laboratories

1/23/2003 EIA Living 

(serum, 

plasma)

Deceased 

donor 

(serum)

As reported on its package insert, on 21 seroconversion panels, the 

GS HBsAg EIA 3.0 detected infection at the same time or earlier 

than the two unnamed licensed EIA comparison tests.193

-

HBV 

(anti-HBs; 

antibodies to 

the surface 

antigen)

Ortho 

Antibody to 

HBsAg 

ELISA Test 

System 3†

Ortho Clinical 

Diagnostics

4/23/2003 EIA Serum, 

plasma

In the FDA product label for Cobas AmpliScreen HBV test, on 

40 seroconversion panels Ortho HBsAg System 3 detected HBV 

a median of 14 to 18 days later than the NAT, depending on 

preparation method.185

In company marketing materials for Genetic Systems HBsAg EIA, 

the window period for the GS test and this Ortho test was the same 

for 10 of 21 commercial seroconversion panels. For the remaining 

11, GS detected reactive results sooner.197

-
360

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

HBV 

(anti-HBc; 

antibodies to 

the core 

antigen)

Abbott 

AxSYM Core 

2.0

Abbott 

Laboratories

9/8/2006 

original 

approval; 

2/5/2007 

manufacturin

g and 

packaging 

change

Microparticle 

EIA

Living 

(serum, 

plasma)

- -

Abbott 

PRISM 

HBcore

Abbott 

Laboratories

10/13/2005 ChLIA Living

(serum, 

plasma)

The product label states, “Anti-HBc appears in the serum of patients 

infected with HBV one to four weeks after the appearance of HBsAg, 

at the onset of symptoms.”187

-

ADVIA 

Centaur HBc 

Total Assay

Siemens 

Healthcare 

Diagnostics

12/22/2004 ChLIA Living 

(serum, 

plasma)

The product labeling reports that, in a study of 7 seroconversion 

panels, the Advia Centaur detected infection at the same time as the 

(unnamed) reference in 6 panels and one day sooner in the 

seventh.186

-

CORZYME† Abbott 

Laboratories

3/19/1991 

initial 

approval

EIA Living 

(serum, 

plasma)

- -

Ortho HBc

ELISA Test 

System†

Ortho Clinical 

Diagnostics

4/18/1991 EIA Living 

(serum, 

plasma)

In a U.K. Health Protection Agency-sponsored evaluation of the 

ORTHO HBc ELISA Test System, the test was evaluated in four 

seroconversion panels. All evaluated HBc tests detected the same 

number of samples.198

-
361

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

HCV Abbott 

AxSYM AntiHCV

Abbott 

Laboratories

2/5/2004 

initial; 

6/30/2004; 

12/3/2004, 

12/14/2004, 

1/31/2005, 

2/5/2007 

manufacturing 

changes; 

2/22/2008 

labeling 

changes

Microparticle 

EIA

Living 

(serum)

In an independent laboratory evaluation sponsored by the U.K.

Medical Devices Agency, AxSYM HCV v.3 and six other HCV tests 

were evaluated. On 22 seroconversion panels and 2 performance 

panels AxSYM detected HCV a mean of 1.6 days after the most 

sensitive assay for a given panel (ranking #2 out of all the tests), 

compared with 1.1 for Vitros ECi anti-HCV (which ranked first).178

In an evaluation sponsored by the U.K. Health Protection Agency on 

19 seroconversion panels, the Monolisa HCV Ab/Ab Ultra detected 

infection a mean of 4.8 days after PCR at a 0.5 threshold, and 

7.5 days after PCR at a 1.0 threshold. For either threshold the range 

of days to detection was 0-32. By comparison, AxSYM HCV v. 3.0

detected HCV a mean of 19.7 days (range: 0-38) after PCR.182

-

Abbott HCV 

EIA 2.0

Abbott 

Laboratories

7/22/2004 EIA Living 

(serum, 

plasma), 

Deceased 

donor 

(serum)

Of 19 blood donors who were RNA-positive but initially EIA-2 

antibody negative, EIA-2 was positive at follow-up a median of 63 

days later, but 4 of the samples were still not EIA-2 reactive on the 

last follow-up sample available (at 23 days, 93 days, 317 days, and 

190 days, respectively). For comparison, 8 of the donors were EIA-3 

positive at initial test, 9 more were reactive at first follow-up, and all 

were reactive by second follow-up. So, by the last follow-up time 

EIA-3 was positive for all donors, but for 4 of them EIA-2 was never 

reactive within the duration of the study. Intervals between blood 

draws were long, the authors noted.141

-
362

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

ADVIA 

Centaur HCV 

assay 

Siemens 

Healthcare 

Diagnostics

12/22/2004 

initial; 

3/4/2009 

manufacturing 

process 

change; 

4/9/2009 

trade name 

labeling 

change

ChLIA Living 

(serum, 

plasma)

Advia detected infection a mean of 34.6 days (range: 6 to 182 days) 

from the initial draw date on 20 panels.139

In a study with two panels, Advia detected infection on bleed day 11 

on one and day 28 on the other.146

In its FDA submission of Summary of Safety and Effectiveness data, 

on 23 seroconversion panels, Advia Centaur was “at least as 

sensitive in the detection of seroconversion for HCV as commercially 

available assays,” compared with published data.

In the same document, on 20 seroconversion panels Centaur 

detected HCV on the same day as Ortho HCV v. 3.0 in 14 series, 

three days later in one, and a mean of 3.25 days sooner on the 

remaining 4.188

-
363

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

Ortho HCV 

Version 3.0 

ELISA Test 

System

Ortho Clinical 

Diagnostics

5/20/1996; 

changes to 

package 

insert and 

indications 

2/9/2009

EIA Living 

(serum, 

plasma), 

Deceased 

donor 

(serum, 

EDTA)

8 of 19 blood donors who were RNA-positive but initially EIA-2 

antibody negative were EIA-3 reactive. 17 of the 19 were reactive 

when recalled for additional testing a median of 34 (range: 5 to 70) 

days later, and all were reactive by the next follow-up. This includes 

4 who were EIA-2 negative for the entire duration of the study, with 

blood last tested at 23 days, 93 days, 190 days, and 317 days, 

respectively.. Intervals between blood draws were long, the authors 

noted.141

The mean time to detect infection in transfusion recipients was 

74 days post-transfusion(range: 26 to 118 days). 

15/21 cases were detected in the same bleed by Ortho 3.0 and the 

second generation version. In the other 5, this test detected infection 

a mean of 26 days (range: 20 to 34 days) earlier than the second 

generation version.135

In a study with two panels, this test detected infection on bleed 

day 11 day on one and day 14 on the other.146

In the FDA product label for COBAS AmpliScreen HCV Test 2.0, on 

9 seroconversion panels it detected HCV a mean of 32 days before 

seroconversion, defined as positive results on both Ortho 3.0 EIA

and Chiron RIBA 3.0.184

In its FDA submission of Summary of Safety and Effectiveness data 

and product label, on 20 seroconversion panels Centaur detected 

HCV on the same day as Ortho HCV v. 3.0 in 14 series, three days 

later in one, and a mean of 3.25 days sooner on the remaining 4.188

-
364

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

Tests Currently in Use by U.S. Organ Procurement Organizations (OPOs): Nucleic Acid Tests (NAT)

HIV NAT COBAS 

AmpliScreen 

HIV-1 Test v. 

1.5

Roche 

Diagnostics

12/20/2002 

initial 

approval; 

12/19/2003 

expanded 

indications; 

3/9/2005 

expanded 

indications; 

5/23/2007 

changes in 

labeling and 

directions

PCR Living 

(plasma); 

Deceased 

donor 

(serum, 

plasma)

Based upon modeling, the window period was about 12 hours 

(95% CI: 5 to 19 hours) less than the Gen-Probe TMA HIV-NAT 

test.137

In 10 seroconversion panels, this test was positive 2 to 14 days 

(range) days before antibody seroconversion and 0 to 28 days 

(range) before p24 antigen test.172

In 10 seroconversion panels, this test was positive 7 to 17 days 

before antibody seroconversion tested with anti-HIV-1 Ortho AntiHIV1/2 Test.173

According to its FDA product label, AmpliScreen HIV Test v.1.5 

detected HIV a mean of 12 days before Abbott HIV-1-2 antibody test 

on 41 seroconversion panels, 6.8 days before the Abbott p24 

antigen test on 40 panels, and 4.4 days before the Coulter p24 

antigen test on 38 panels, using the multiprep procedure. 

As reported in its FDA product label, this test detected HIV a mean 

of 14.2 days before Abbott HIV-1-2 antibody test on 41 panels, 

8.3 days before the Abbott p24 antigen test on 40 panels, and 

5.8 days before the Coulter p24 antigen test on 38 panels using the 

standard processing procedures.192

Also reported in its FDA product label, COBAS HIV-1 Test v. 1.5 was 

evaluated on 10 plasma seroconversion panels. COBAS v.1.5 

recognized HIV a mean of 12 days before Abbott HIV-1/2, 7.5 days 

before Abbott HIV-1 p24 Antigen, and 4.3 days before Coulter HIV-1 

Antigen test.192

One study 

reported the 

turnaround time 

of two hours.133
365

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

HCV NAT COBAS 

AmpliScreen 

HCV Test 

version. 2.0

Roche 

Diagnostics

12/3/2002 

original 

approval; 

5/13/2004 

expanded 

indications; 

3/9/2005 

expanded 

indications; 

5/22/2007 

labeling

PCR Living 

(plasma), 

Deceased 

donor 

(serum, 

plasma)

Based upon modeling, the window period was about 14 hours 

(95% CI: 10 to 9 hours) less than the Gen-Probe TMA HCV-NAT 

test.137

In 4 of 5 seroconversion panels, the AmpliScreen test returned 

positive results 23 to 32 days before seroconversion panels. In the 

other panel, it detected infection later164

On 44 blood donor samples in the window period, this test returned 

positive results a mean of 5.1 days (range: 0 to 24 days) before 

Monolisa HCV Ag-Ab testing.150

In the FDA product label for COBAS AmpliScreen HCV Test 2.0, on 

9 seroconversion panels it detected HCV a mean of 32 days before 

seroconversion, defined as positive results on both Ortho 3.0 EIA 

and Chiron RIBA 3.0.184

One study 

reported the 

turnaround time 

as two hours.133

HBV NAT COBAS 

AmpliScreen 

HBV Test

Roche 

Diagnostics

4/21/2005 

original 

approval; 

8/2/2005 

additional 

indications;

8/16/2007 

labeling 

changes

PCR Living 

(plasma), 

Deceased 

donor 

(serum, 

plasma)

Using 5 seroconversion panels this test was positive a mean of 

10 days (range: 4 to 18 days) before HBsAg in single-sample 

procedure; mean 3.7 days (0 to 11) with minipool.160

In the FDA product label, in 40 seroconversion panels this test had a 

window period of 15 (SD: 17) days fewer than Ortho 3 for HBsAg 

using multiprep procedure and 20 (SD: 17) days fewer using the 

standard preparation.185

-
366

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

HIV-1 and 

HCV NAT

ProCleix 

HIV-1/HCV 

Assay

Gen-Probe 

Incorporated

2/27/2002 

initial 

approval; 

6/4/2004 

expanded 

indications

TMA Living 

(plasma), 

Deceased 

donor 

(serum, 

plasma)

Based upon modeled data and compared with AmpliScreen, the 

window period with ProCleix for HIV is an estimated 12 hours 

(95% CI: 5 to 19 hours) less, and for HCV it was an estimated 

14 hours (95% CI: 5 to 19 hours).137

HIV:

In two seroconversion panels, ProCleix was positive 7 to 10 days 

before p24 antigen and 12 to 14 days before an antibody test for 

HIV.138

In 26 seroconversion panels, ProCleix was positive for HIV at a 

mean of 10.2 bleed days (range: 0 to 61), compared with 12.3 

(range: 1 to 61) for PCR, 16.9 (range: 1 to 67) for HIV-1 antigen, and 

24.5 (range: 9 to 74) for HIV-1 antibody. The window period was 

reduced by a mean of 14.6 (SD: 6.2) days compared with antibody 

testing and a mean of 6.6 (SD: 4.4) days compared with antigen 

testing.148

In 10 HIV seroconversion panels, ProCleix tested neat was positive 

a median of 12 days (neat) or 10 days (diluted 1:16) before antibody 

test (HIV 1/2 antibody assay by Abbott). It was positive a median of 

7 days (neat) or 3 days (diluted) before p24 antigen test (Abbott or 

Coulter). The discriminatory assay was positive a median of 12 days 

before the antibody test and 6 days before the antigen test.128

In its product label, on 10 HIV seroconversion panels ProCleix 

detected infection a median of 10 days before Abbott HIV-1/2 and 

3 days before the Abbott or Coulter p24 antigen test in a 1:16 

dilution. The discriminatory assay tested neat detected infection a 

median of 12 days before the antibody test and 6 days before the 

antigen tests. ProCleix recognized HIV before the comparators in

8 panels and at the same time as the other two.191

One study 

reported an 

“experienced 

operator” required 

6 hours to 

perform two 

HIV/HCV tests, 

and 6.5 hours to 

perform three.138
367

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

HCV:

In 2 seroconversion panels, one of the HCV panels had “similar” 

findings; the other had an 85 day difference between detection of 

HCV RNA and confirmed 3rd generation antibody test.138

In 25 seroconversion panels, ProCleix detected HCV a mean of 

113.2 (Standard Deviation [SD]: 98.7) days before a 2nd generation 

anti-HCV assay and 80.5 (SD: 55.9) days before a 3rd-generation 

assay.145 (The window period for HIV was not reported in the article.)

In 24 seroconversion panels, ProCleix detected HCV at a mean of 

12 days (range: 0 to 140) compared with 13.35 for PCR (of the 

20 panels tested, range: 0 to 140) and 37.9 (range: 5 to 186) for 

antibody test. Compared with an antibody test, this test had a 

mean reduction of 25.8 (SD: 15.5) day reduction in detection.

148

In 10 HCV seroconversion panels, ProCleix (including the 

discriminatory assay) was positive a median of 25 days before the 

antibody test (Ortho 3.0).128

In its product label, on 10 HCV seroconversion panels, 

ProCleix detected HCV sooner than the Ortho HCV 3.0 ELISA or the 

Abbott Anti-HCV 2.0 for every series, and a median of 25 earlier 

whether diluted or not.

191

Tests not currently in use in U.S. Organ Procurement Organization (OPO): 4th generation Immunoassays

HIV 

4th generation

ARCHITECT 

HIV Combo

Abbott 

Laboratories

Not FDA 

Approved

Micropart

icle 

ChLIA 

(CMIA)

Serum or 

plasma

In 24 seroconversion panels, ARCHITECT HIV Combo was positive 

at mean of 13.1 days (range: 1 to 37).154

In 3 panels, it was positive on day 8 in two and day 23 on the 

third.149

In an evaluation funded by the U.K. Health Protection Agency on 

18 seroconversion panels, the mean delay (range) in days of the 

Architect HIV Ag/Ab Combo was 0.9 (0-6) compared with the most 

sensitive assay. (For AxSYM HIV Ag/Ab Combo this was 0.6 (0-7); 

Genscreen Ultra HIV Ag-Ab 1.5 (0-7); Murex HIV Ag/Ab Combo 4.8 

(0-53); Vironostika HIV Uni-Form II Ag/Ab 8.6 (0-57)).177

Run time 

26 minutes154

Or, 29 minutes 

per company 

marketing 

materials174

Or, 30 minutes in 

an independent 

evaluation177
368

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

AxSYM HIV 

Ag/Ab 

Combo

Abbott 

Laboratories

Not FDA 

Approved

Microparticle 

EIA

Serum or 

plasma

In 24 seroconversion panels, AxSYM HIV Ag/Ab Combo was 

positive at mean of 14.8 days (range: 1 to 37).156

In 19 seroconversion panels, it was positive at a mean of 13.2 days 

(range: 1 to 35).158

In 14 seroconversion panels it detected HIV at a mean of 24.6 days 

(range: 7 to 50).136

In 3 seroconversion panels it detected HIV at 15, 23, and 34 days.149

In 25 seroconversion panels, it detected HIV a mean of 0.44 days 

(range: 0-5 days) after the first assay (which varied by panel).156

This was 2-3 days before the 3rd-generation assays.

In 22 panels, compared with a 3rd generation test (AxSYM gO), 

the window period was reduced by a mean of 6.15 days.163 It was 

positive first by 1 to 2 bleeds in 18 of the panels, and equal in the 

other 4.

In an evaluation funded by the U.K. Health Protection Agency on 

18 seroconversion panels, the mean delay (range) in days of the 

Architect HIV Ag/Ab Combo was 0.9 (0-6) compared with the most 

sensitive assay. (For AxSYM HIV Ag/Ab Combo this was 0.6 (0-7); 

Genscreen Ultra HIV Ag-Ab 1.5 (0-7); Murex HIV Ag/Ab Combo 4.8 

(0-53); Vironostika HIV Uni-Form II Ag/Ab 8.6 (0-57)).177

In an evaluation by the U.K. Medicines and Healthcare products 

Regulation Agency of 35 seroconversion panels, AxSYM Ag/Ab 

combo was always the first positive test out of the other tested 

4th and 3rd generation assays. By comparison, the mean (range) of 

days longer for positivity by Murex HIV Ag/Ab Combination were 

2.4 (0-53), Genscreen PLUS HIV Ag-Ab were 3.6 (0-53), and 

Vironostika HIV Uni-Form II Ag/Ab 5.9 (0-57).179

In an evaluation of the Genscreen ULTRA HIV Ag-Ab funded by the 

U.K. Health Protection Agency, in 21 seroconversion panels, this 

test detected HIV a mean of 1 day (range: 0-6) after AxSYM (the 

earliest test). By comparison, Murex HIV Ag/Ab Combination 

detected HIV a mean of 3.8 days (range: 0-53) days later, and 

Vironostika HIV Uni-Form II Ag/Ab detected HIV a mean of 7.3 

(range: 0-57) days later.181

Run time 

40 minutes154

Time to 

completion about 

2 hours for 

90 specimens in 

a Health 

Protection 

Agency 

evaluation.

179
369

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

COBAS Core 

HIV Combi

Roche 

Diagnostics

Not FDA 

Approved

EIA Of 24 seroconversion panels, COBAS Core Combi only recognized 

HIV in 23 of the sample sets. Of those 23, the mean time to positive 

test result was 16.8 days (overall range 1 to never within panel 

set).154

In 94 seroconversion panels, compared with 3rd generation tests the 

window period was reduced by 3.6 to 5.7 days.170

In 87 panels in the same study, it detected HIV a mean of 2.75 days 

after RT-PCR.170

Run time 

75 minutes154

Coulter 

HIV-1 p24 

Antigen 

Assay

Coulter 

Corporation

Not FDA 

Approved

EIA Plasma, 

serum, or 

tissue 

culture 

supernatants

In the package insert, on 5 seroconversion panels the Coulter test 

detected HIV antigen prior to antibodies (tested by Abbott HIVAB 

HIV-1 antibody EIA test) on 4 tests, by 21 days, 23 days, 42 days, 

and 28 days. In the other panel, antigen was not detected.180

The package insert also reported on findings on 31 seroconversion 

panels by “independent investigators.” Window period was 

compared with Abbott HIVAB HIV-1/HIV-2 (rDNA) EIA and 

GS HIV-1/HIV-2 EIA, and several investigational tests. The Coulter 

test detected antigen prior to seroconversion in 80.6% of panels, and 

at the same time in 9.7%. Of the three remaining panels, one was 

not RNA-positive either. The Coulter test reportedly detect antigen at 

the same time as the investigational tests detected RNA in the 

rest.180

As reported in its FDA product label, this test detected HIV a mean 

of 14.2 days before Abbott HIV-1-2 antibody test on 41 panels, 

8.3 days before the Abbott p24 antigen test on 40 panels, and 

5.8 days before the Coulter p24 antigen test on 38 panels using the 

standard processing procedures.192

Also reported in its FDA product label, COBAS HIV-1 Test v. 1.5 was 

evaluated on 10 plasma seroconversion panels. COBAS v.1.5 

recognized HIV a mean of 12 days before Abbott HIV-1/2, 7.5 days 

before Abbott HIV-1 p24 Antigen, and 4.3 days before Coulter HIV-1 

Antigen test.

192

Total test time 

4 hours.171
370

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

Enzygnost 

HIV Integral 

II

Siemens 

Healthcare 

Diagnostics

Not FDA 

Approved

EIA Serum, 

plasma

In a WHO/UNAIDS evaluation, Enzygnost HIV Integral II detected 

HIV a mean of 1 day (range: 0 to 2) earlier than Enzygnost HIV 1/2 

Plus, using 8 seroconversion series. By comparison, means were 

0.9 for Genscreen Plus HIV Ag/Ab, - 0.9 for Murex HIV Ag/Ab 

Combination, and -0.7 for Vironostika HIV Uni-Form II Ag/Ab.199

Total time 2 hours 

50 minutes for 

96 sera, 

according to 

WHO/UNAIDS 

report 15.199

Genscreen 

Plus HIV 

Ag/Ab 

Combo

Bio-Rad 

Laboratories

Not FDA 

Approved

EIA Serum, 

plasma

In an evaluation by the U.K. Health Protection Agency on 

18 seroconversion panels, the mean delay (range) in days of the 

Architect HIV Ag/Ab Combo was 0.9 (0-6) compared with the most 

sensitive assay. (For AxSYM HIV Ag/Ab Combo this was 0.6 (0-7); 

Genscreen Ultra HIV Ag-Ab 1.5 (0-7); Murex HIV Ag/Ab Combo 

4.8 (0-53); Vironostika HIV Uni-Form II Ag/Ab 8.6 (0-57)).177

In an evaluation funded by the U.K. Medical Devices Agency of 

38 seroconversion panels, the Murex Combo test detected HIV a 

mean of 3.9 days (range: 0 to 20) before the most sensitive antibody 

test. By comparison, the mean (range) was 2.76 (0 to 20) for 

Genscreen PLUS HIV Ag-Ab and 0.34 (-9 to 20) for Vironostika UniForm II Ag/Ab.183

In an evaluation funded by the U.K. Medicines and Healthcare 

products Regulation Agency of 35 seroconversion panels, AxSYM 

Ag/Ab combo was always the first positive test out of the other 

tested 4th and 3rd generation assays. By comparison, the mean 

(range) of days longer for positivity by Murex HIV Ag/Ab 

Combination were 2.4 (0-53), Genscreen PLUS HIV Ag-Ab were 

3.6 (0-53), and Vironostika HIV Uni-Form II Ag/Ab 5.9 (0-57).179

In a WHO/UNAIDS evaluation on 8 seroconversion panels, 

Genscreen Plus HIV Ag/Ab was positive a mean of 0.9 days 

(range: -0.1 to 1.75 days) earlier than the reference assay, 

Enzygnost HIV1/2 Plus. By comparison, means were

-1 for Enzygnost HIV Integral II, -0.9 for Genscreen Plus, 

-0.9 for Murex HIV Ag/Ab Combination, and -0.7 for Vironostika HIV 

Uni-Form II Ag/Ab.199

Total time 3 hours 

for 96 tests, 

according to 

WHO/UNAIDS 

report 15199

Or 152 minutes in 

an independent 

laboratory 

evaluation.181
371

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

Genscreen 

HIV Ultra AgAb Assay

Bio-Rad 

Laboratories

Not FDA 

Approved

EIA In 24 seroconversion panels, Genscreen HIV Ultra Ag-Ab was 

positive at mean of 18.3 days (range: 1 to 37).154

In an evaluation of the Genscreen ULTRA HIV Ag-Ab funded by the 

U.K. Health Protection Agency, in 21 seroconversion panels, this 

test detected HIV a mean of 1 day (range: 0-6) after AxSYM (the 

earliest test). By comparison, Murex HIV Ag/Ab Combination 

detected HIV a mean of 3.8 days (range: 0-53) days later, and 

Vironostika HIV Uni-Form II Ag/Ab detected HIV a mean of 7.3 

(range: 0-57) days later.181

Approximate time 

to completion 

152 minutes, 

according to the 

U.K. Health 

Protection 

Agency.181

Modular HIV 

Combi

Roche 

Diagnostics

Not FDA 

Approved

EIA Of 24 seroconversion panels, Modular Combi only recognized HIV in 

23 of the sample sets. Of those 23, the mean time to positive test 

result was 15.4 days (overall range 1 to never within panel set).154
372

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

Murex HIV 

Ag/Ab 

Combo

Abbott 

Laboratories

Not FDA 

Approved

EIA Serum, 

plasma

Of 24 seroconversion panels, Murex Combo only recognized HIV in 

23 of the sample sets. Of those 23, the mean time to positive test 

result was 14.6 days (overall range 1 to never within panel set).154

In 19 seroconversion panels, it recognized HIV in 16 of the sample 

sets. Of those 16, the mean time to positive test was 15 days 

(overall range 1 to never within panel set).158

In 25 seroconversion panels it recognized HIV a mean of 0.92 days 

(range:0-15 days) after the first assay (which varied by panel).156

This was about 1.5 days before the 3rd generation assays.

In an evaluation funded by the U.K. Health Protection Agency on 

18 seroconversion panels, the mean delay (range) in days of the 

Architect HIV Ag/Ab Combo was 0.9 (0-6) compared with the most 

sensitive assay. (For AxSYM HIV Ag/Ab Combo this was 0.6 (0-7); 

Genscreen Ultra HIV Ag-Ab 1.5 (0-7); Murex HIV Ag/Ab Combo 

4.8 (0-53); Vironostika HIV Uni-Form II Ag/Ab 8.6 (0-57)).177

In an evaluation by the U.K. Medical Devices Agency of 

38 seroconversion panels, the Murex Combo test detected HIV a 

mean of 3.9 days (range: 0 to 20) before the most sensitive antibody 

test. By comparison, the mean (range) was 2.76 (0 to 20) for 

Genscreen PLUS HIV Ag-Ab and 0.34 (-9 to 20) for Vironostika Uni-

Form II Ag/Ab.183

In an evaluation funded by the U.K. Medicines and Healthcare 

products Regulation Agency of 35 seroconversion panels, AxSYM 

Ag/Ab combo was always the first positive test out of the other 

tested 4th and 3rd generation assays. By comparison, the mean 

(range) of days longer for positivity by Murex HIV Ag/Ab 

Combination were 2.4 (0-53), Genscreen PLUS HIV Ag-Ab were 

3.6 (0-53), and Vironostika HIV Uni-Form II Ag/Ab 5.9 (0-57).179

In an evaluation of the Genscreen ULTRA HIV Ag-Ab funded by the 

U.K. Health Protection Agency, in 21 seroconversion panels, this 

test detected HIV a mean of 1 day (range:0-6) after AxSYM (the 

earliest test). By comparison, Murex HIV Ag/Ab Combination

detected HIV a mean of 3.8 days (range:0-53) days later, and 

Vironostika HIV Uni-Form II Ag/Ab detected HIV a mean of 7.3 

(range:0-57) days later. By comparison, means were -1 for 

Enzygnost HIV Integral II, -0.9 for Genscreen Plus HIV Ag/Ab, 

-0.7 for Vironostika HIV Uni-Form II Ag/Ab.181

Total time to run 

assay 2 hours 

55 minutes 

according to 

WHO/UNAIDS 

report 15.199

Run time 

120 minutes183

Time to

completion 

140 minutes, as 

reported in a 

U.K. Medical 

Devices Agency 

report
373

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

VIDAS DUO 

QUICK

bioMerieux 

Clinical 

Diagnostics

Not FDA 

Approved

EIA In 24 seroconversion panels, VIDAS DUO QUICK was positive 

at mean of 13.2 bleeding days (range: 1 to 37).154

On the manufacturer Web site, on 25 seroconversion panels there 

was a mean delay of 1.44 days in HIV detection compared to an 

RNA test.176

Run time 

80 minutes154

VIDAS DUO 

ULTRA

bioMerieux 

Clinical 

Diagnostics

Not FDA 

Approved

EIA In 14 seroconversion panels, VIDAS DUO ULTRA was positive at a 

mean of 23.5 days (range: 2 to 47)136

In 24 seroconversion panels, it was positive at mean of 13.5 days 

(range: 1 to 30).154

In 19 seroconversion panels, it was positive a mean of 16.2 days 

(range: 1 to 35).158

In 16 seroconversion panels, it was positive at a mean of 2.31 days 

(range: 0 to 20) after RT-PCR.169

Compared with the most sensitive antibody test in the test’s 

information enclosure, on 10 seroconversion panels it detected HIV 

one bleed earlier in 2 cases, 2 bleeds earlier in 3, 3 bleeds earlier in 

4, and 5 bleeds earlier in 1.161

On the same panels compared with the most sensitive antigen test, 

it tested infection at the same time in 7 panels, 4 bleeds earlier in 1, 

1 bleed earlier in 1, and 1 bleed later in the other.161

On the company Web site, in 16 seroconversion panels this test 

detected infection at a mean of 2.13 bleeding days (range: 0-20) 

compared with 2.38 (range: 0-22) for an antigen test.175

Run time 

120 minutes154,169

Vironostika 

HIV UniForm II 

Ag/Ab

bioMerieux 

Clinical 

Diagnostics

Not FDA 

Approved

EIA Serum, 

plasma

Of 24 seroconversion panels, Vironostika Uni-Form II Ag/Ab only 

recognized infection in 21. Of those 21, the mean time to positivity 

was 19.3 days (range 1 to never within panel set).156

Of 19 seroconversion panels, it only recognized HIV in 16. Of those 

16, the mean time to positivity was 15.6 days (overall range 1 to 

never within panel set).158

Of 7 seroconversion panels, it was positive on day bleed 7, 15, 47, 

26, 9, 18, and 27, respectively. It was always positive before 

Western blot and was positive from 0 to 37 days before the 

Total time to 

perform assay 

2 hours 

15 minutes, 

according to 

WHO/UNAIDS 

report 15.199

Run time 

90 minutes154,157
374

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

3rd generation Vironostika test.165

In 10 seroconversion panels this test was found to have a window 

period shortened by 6.2 days compared with the 3rd generation 

Vironostika test. This is 2.2 days longer than a HIV-1 p24 antigen 

assay.166

Modeling from the same study suggests a total window period of 

18 days.166

In 30 seroconversion panels, it missed 3 positives. Of the rest, it 

detected HIV at a mean of 17.1 days (overall range 0 to never).157

On the same panels three 3rd generation tests all missed either 3 or 

4 positives, and had means detection at 17.6 days, 20.3 days, and 

23.3 days.

In 25 seroconversion panels, it detected HIV a mean of 2.6 days 

(range: 0 to 19 days) after the most sensitive assay (which varied by 

panel).156 This was about the same as one 3rd generation assay and 

a day sooner than another 3rd generation assay.

In an evaluation by the U.K. Health Protection Agency on 

18 seroconversion panels, the mean delay (range) in days of the 

Architect HIV Ag/Ab Combo was 0.9 (0-6) compared with the most 

sensitive assay. (For AxSYM HIV Ag/Ab Combo this was 0.6 (0-7); 

Genscreen Ultra HIV Ag-Ab 1.5 (0-7); Murex HIV Ag/Ab Combo 

4.8 (0-53); Vironostika HIV Uni-Form II Ag/Ab 8.6 (0-57)).177

In an evaluation funded by the U.K. Medical Devices Agency of 

38 seroconversion panels, the Murex Combo test detected HIV a 

mean of 3.9 days (range: 0 to 20) before the most sensitive antibody 

test. By comparison, the mean (range) was 2.76 (0 to 20) for 

Genscreen PLUS HIV Ag-Ab and 0.34 (-9 to 20) for Vironostika UniForm II Ag/Ab.183

In an evaluation by the U.K. Medicines and Healthcare products 

Regulation Agency of 35 seroconversion panels, AxSYM Ag/Ab 

combo was always the first positive test out of the other tested 4th

and 3rd generation assays. By comparison, the mean (range) of days 

longer for positivity by Murex HIV Ag/Ab Combination were 2.4 (0-

53), Genscreen PLUS HIV Ag-Ab were 3.6 (0-53), and 
375

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

Vironostika HIV Uni-Form II Ag/Ab 5.9 (0-57).179

In an evaluation of the Genscreen ULTRA HIV Ag-Ab by the U.K.

Health Protection Agency, in 21 seroconversion panels, this test 

detected HIV a mean of 1 day (range: 0-6) after AxSYM (the earliest 

test). By comparison, Murex HIV Ag/Ab Combination detected HIV a 

mean of 3.8 days (range: 0-53) days later, and Vironostika HIV UniForm II Ag/Ab detected HIV a mean of 7.3 (range: 0-57) days 

later.

181

In a WHO/UNAIDS evaluation on 8 seroconversion panels, 

Vironostika HIV Uni-Form II Ag/Ab was positive a mean of 0.6 days 

(range: -0.2 to 1.5 days) earlier than the reference assay, Enzygnost 

HIV1/2 Plus. By comparison, means were -1 for Enzygnost HIV 

Integral II, -0.9 for Genscreen Plus HIV Ag/Ab, - 0.9 for Murex HIV 

Ag/Ab Combination.199

HCV INNOTEST 

HCV Ab IV

Innogenetics 

NV

Not FDA 

Approved

EIA Serum, 

plasma

In company marketing materials, on 30 seroconversion panels the 

Innotest HCV Ab IV had a total delay of 22 days for the detection of 

HCV, compared with 122 days for Ortho 3.0 test (a 3rd generation 

assay).196

-
376

Virus

Test Trade 

Name Manufacturer

FDA 

Approval Format*

Specimen 

Collection Window Period

Turnaround 

Time

Monolisa 

HCV Ag/Ab 

Ultra

Bio-Rad 

Laboratories

Not FDA 

Approved

EIA In 10 seroconversion panels, there was a mean delay in positivity 

between the Monolisa HCV Ag/Ab Ultra and MP-NAT of 5.1 days 

(range: 0 to 24 days).150

Compared with Prism HCV EIA (Abbott) (3rd generation EIA), this 

was a reduction of 26.8 days (range: 0 to 72 days).150

In non-commercial conversion panels of 23 hemodialysis patients, 

there Monolisa Ultra detected HCV a mean of 21.6 days before the 

most sensitive antibody test (which varied by panel).151

The mean delay of the Monolisa after RNA assay was 30.3 days. 

The mean delay after the trak-C antigen assay was 27.9 days 

compared with the HCV core Ag quantification assay and 16.3 days 

compared with the HCV Ag blood screening assay.151

In an evaluation funded by the U.K. Health Protection Agency on 

19 seroconversion panels, the Monolisa HCV Ab/Ab Ultra detected 

infection a mean of 4.8 days after PCR at a 0.5 threshold, and 

7.5 days after PCR at a 1.0 threshold. For either threshold the range 

of days to detection was 0-32. By comparison, AxSYM HCV v. 3.0 

detected HCV a mean of 19.7 days (range: 0-38) after PCR.182

Approximate time 

to completion 

190 minutes, 

as reported by 

study funded by 

U.K. Health 

Protection 

Agency.182

Murex 4.0 Abbott 

Laboratories

Not FDA 

Approved

EIA - -

* ChLIA: Chemiluminescent immunoassay; EIA: Enzyme Immunoassay; PCR: Polymerase chain reaction; TMA: Transcription-mediated amplification

† No FDA approval documentation found
377

Table 55. Diagnostic Characteristics

Virus/ Type Test Trade 

Name

Manufacturer Cite Study Type Sensitivity Specificity Data Loss Comments

Samples Reference Sensitivity Samples Reference Specificity

Tests currently in use in U.S. Organ Procurement Organization (OPO): Immunoassays

HIV 3rd

generation 

EIA

Genetics 

System (GS) 

HIV-1/HIV-2 

Plus 0 EIA

Bio-Rad 

Laboratories

Owen et 

al. 2008159

Analytic 621 infected Other 

serological 

tests, 

nucleic acid 

tests (NAT), 

Western blot 

(WB) for 

confirmation

99.8% 513 uninfectedOther 

serological 

tests, NAT, 

WB

99.4% None Positives not 

tested in 

duplicate

HIVAB HIV1/HIV-2 

(rDNA) EIA

Abbott 

Laboratories

Barbe et 

al. 1994134

Analytic 7 infected Archived 

samples

100% 1,546 

negative

Repeat 

testing, 

BioMerieux 

Assay, WB

99.74% None

Owen et 

al. 2008159

Analytic 621 infected Other 

serological 

tests, NAT, 

WB for 

confirmation

99.4% 513 uninfectedOther 

serological 

tests, NAT, 

WB

97.7% None Positives not 

tested in 

duplicate

HBV 

(HBsAg; 

the surface 

antigen)

Abbott 

AxSYM 

HBsAg Assay

Abbott 

Laboratories

Diepersloo

t et al. 

2000140

Clinical 200 Abbott IMx 

and DPC 

IMMULITE 

assays. 

Discrepanci

es by 

confirmatory 

assay

100% 200 Abbott IMx 

and DPC 

IMMULITE 

assays

99.4% None

Abbott PRISM 

HBsAg 

Abbott 

Laboratories

None 

identified

- - - - - - - - -
378

Virus/ Type Test Trade 

Name

Manufacturer Cite Study Type Sensitivity Specificity Data Loss Comments

Samples Reference Sensitivity Samples Reference Specificity

ADVIA 

Centaur 

HBsAg Assay

Siemens 

Healthcare 

Diagnostics

Huzly et al. 

2008142

Analytic 139 Consensus 

by >6 of 

9 assays

100% 47 

(exclude 

vaccinated)

Consensus 

by >6 of 

9 assays 

97.9% Not all 

patients 

included for 

calculation of 

sensitivity 

and 

specificity 

due to 

vaccination 

history.

Patients 

unselected 

at enrollment 

but included 

for sensitivity 

or specificity 

retrospectively based 

upon 

vaccination 

history

Genetic 

Systems (GS) 

HBsAg EIA 

3.0

Bio-Rad 

Laboratories

None 

identified

- - - - - - - - -

HBV 

(anti-HBs; 

antibodies 

to the 

surface 

antigen)

Ortho 

Antibody to 

HBsAg ELISA 

Test System 3

Ortho Clinical 

Diagnostics

None 

identified

- - - - - - - - -

HBV 

(anti-HBc; 

antibodies 

to the core 

antigen)

Abbott PRISM 

HBcore

Abbott 

Laboratories

None 

identified

- - - - - - - - -

ADVIA 

Centaur HBc 

Total Assay

Siemens 

Healthcare 

Diagnostics

None 

identified

- - - - - - - - -

AxSYM Core 

2.0

Abbott 

Laboratories

None 

identified

- - - - - - - - -

CORZYME Abbott 

Laboratories

None 

identified

- - - - - - - - -

Ortho HBc

ELISA Test 

System

Ortho Clinical 

Diagnostics

None 

identified

- - - - - - - - -
379

Virus/ Type Test Trade 

Name

Manufacturer Cite Study Type Sensitivity Specificity Data Loss Comments

Samples Reference Sensitivity Samples Reference Specificity

HCV Abbott HCV 

EIA 2.0

Abbott 

Laboratories

Anderson 

et al. 

1995132

Clinical 21,432 Ortho AntiHCV 2.073.2% 

(64.6% to 

80.7%)*

21,432 Ortho AntiHCV 2.099.9% 

(99.9% to 

100%*

None Positives 

tested in

duplicate

Additional 

tests were 

used but 

results 

reported with 

respect to 

the 2.0 EIA 

reported

Laycock et 

al. 1997152

Clinical 101 Matrix HCV 

RIBA

100% 101 Matrix HCV 

RIBA

92.7% None

Leon et al. 

1993153

Clinical 496 Consensus 

by 11 tests 

plus supplemental 

confirmatory 

assays

85.7% 

(80.5% to 

89.9%)*

496 Consensus 

by 11 tests

99.8% 

(99.7% 

99.9%)*

4 

indeterminate 

(0.8%)

ADVIA 

Centaur HCV 

assay

Siemens 

Healthcare 

Diagnostics

Denoyel et 

al. 2004139

Analytic 472 

presumed 

infected

Abbott 

AxSYM 3.0, 

verification 

of positives 

with Chiron 

RIBA 3.0

100% 

(99.18% to 

100%)

5,228 Abbott 

AxSYM 3.0

99.9% 

(99.78% to 

99.97%)

For 

sensitivity,

3.4% 

(16 samples) 

excluded. For 

specificity, 

0.08% 

(4 samples) 

excluded.

Based upon 

repeated 

testing

Kita et al. 

2009146

Clinical 500 Consensus 

of 

9 screening 

assays and 

PCR 

100% 

(85.8% to 

100%)*

500 Consensus 

of 

9 screening 

assays and 

PCR 

94.4% 

(91.1% to 

96.3%)*

None PCR used 

as reference 

standard 

instead of 

RIBA here to 

avoid data 

loss
380

Virus/ Type Test Trade 

Name

Manufacturer Cite Study Type Sensitivity Specificity Data Loss Comments

Samples Reference Sensitivity Samples Reference Specificity

AxSYM AntiHCVAbbott 

Laboratories

No studies - - - - - - - - -

Ortho HCV 

Version 3.0 

ELISA Test 

System

Ortho Clinical 

Diagnostics

Kita et al. 

2009146

Clinical 500 Consensus 

of 

9 screening 

assays and 

PCR 

100% 

(89.7% to 

100%)*

500 Consensus 

of 

9 screening 

assays and 

PCR

95.5% 

(93.2% to 

97.2%)

None PCR used 

as reference 

standard 

instead of 

RIBA here to 

avoid data 

loss

Vrielink et 

al. 1995167

Clinical 2,153 Ortho 2.0, 

PCR, and 

RIBA-2

100% 2,153 Ortho 2.0 99.7% 

(99.4% to 

99.9%)

No data loss 

(because 

PCR used as 

reference 

standard 

instead of 

RIBA)

Vrielink et 

al. 1995168

Analytic 868 high 

probability 

infected

Murex 3.0 

EIA and 

Abbott 3.0 

EIA, PCR 

confirmation

100% 1,055 unselected Murex 3.0 

EIA and 

Abbott 3.0 

EIA

99.9% No data loss 

(because 

PCR used as 

reference 

standard 

instead of 

RIBA)

Tests currently in use in U.S. Organ Procurement Organization (OPO): NAT

HIV NAT COBAS 

AmpliScreen 

HIV-1 Test v. 

1.5

Roche 

Diagnostics

Bamaga et 

al. 2006133

Clinical 3,288 Enzygnost 

HCV (EIA)

7.7% (0% to 

52.8%)

(Note: 

EIA used as 

reference 

standard)

3,288 Enzygnost 

HCV (EIA)

100% 

(99.9% to 

100%)

None 0.5 was 

added to TP 

and FP 

(which were 

zero) to 

enable 

calculation.

Owen et 

al. 2008159

Analytic 621 infected Other 

assays, 

NAT, WB

92.6% 513 uninfectedOther 

assays, 

NAT, WB

96.9% None
381

Virus/ Type Test Trade 

Name

Manufacturer Cite Study Type Sensitivity Specificity Data Loss Comments

Samples Reference Sensitivity Samples Reference Specificity

HCV NAT COBAS 

AmpliScreen 

HCV Test 

version. 2.0

Roche 

Diagnostics

Bamaga et 

al. 2006133

Clinical 3,288 AxSYM 3.0 

HCV EIA

20% (8.4% 

to 36.9%)

(Note: 

EIA used as 

reference 

standard)

3,288 AxSYM 3.0 

HCV EIA

99.4% (99% 

to 99.6%)

None

HBV NAT COBAS 

AmpliScreen 

HBV Test

Roche 

Diagnostics

Kleinman 

et al. 

2005147

Clinical 581,790 HBsAg, 

anti-HBc, 

and 

follow-up 

if discordant

84.8% 

(79.2% to 

100%)*

581,790 HBsAg, antiHBc, and 

follow-up if 

discordant

100% (100% 

to 100%)*

None

HCV and 

HIV-1 NAT

ProCleix 

HIV-1/HCV 

Assay

Gen-Probe 

Incorporated

Jackson et 

al. 2002144

– HIV

Clinical 530 Serology, 

p24 antigen 

(Ag), 

alternate 

NAT, re-test 

at follow up 

if 

inconclusive

100% 

(85.2% to 

100%)*

530 Serology, 

p24 Ag, 

alternate 

NAT, re-test 

at follow up 

if 

inconclusive

100% 

(99.3% to 

100%)*

1.7% data 

loss due to 9 

inconclusive 

samples

Tested neat

Vargo et 

al. 2002128

– HIV 

Analytic 1,040 

infected

Clinical 

status

99.9% 

(99.4% to 

100%) 

192,288 Serology, 

with WB 

and/or 

immunofluor

escence 

(IFA), if 

needed

99.67% 

(99.55% to 

99.77%) 

overall

44 (2%) of all 

samples 

used in 

sensitivity in 

this study (for 

both viruses) 

were 

excluded

Positives 

tested neat

Jackson et 

al. 2002144

– HCV

Clinical 520 Serology, 

alternate 

NAT, re-test 

at follow-up 

if 

inconclusive

99.3% 

(97.3% to 

99.9%)

520 Serology, 

alternate 

NAT, re-test 

at follow-up 

if 

inconclusive

97.4% 

(94.4% to 

99.0%)

3.5% data 

loss due to 

19 

inconclusive 

samples
382

Virus/ Type Test Trade 

Name

Manufacturer Cite Study Type Sensitivity Specificity Data Loss Comments

Samples Reference Sensitivity Samples Reference Specificity

Vargo et 

al. 2002128

– HCV

Analytic 1,015 

infected

Clinical 

status

99.6% 

(98.9% to 

99.9%)

192,288 Serology, 

RIBA, 

follow-up 

if needed

99.6% 44 (2%) of 

all samples 

used in 

sensitivity in 

this study (for 

both viruses) 

were 

excluded

Tested neat

Vargo et 

al. 2002128

– Coinfected

Analytic 180 coinfectedClinical 

status

100% (98% 

to 100%)

192,288 Serology 

(as above 

for HIV and 

HCV 

separately)

100% 44 (2%) of 

all samples 

used in 

sensitivity in 

this study (for 

both viruses) 

were 

excluded

Tested neat

Tests currently not in use in U.S. Organ Procurement Organization (OPO): 4th generation Immunoassays

HIV 4th

generation 

EIA

ARCHITECT 

HIV Combo

Abbott 

Laboratories

Kwon et al. 

2006149

Analytic 149 infected Known 

samples

100% 412 uninfectedKnown 

samples

99.6% None

Ly et al. 

2007154

Analytic 553 infected 10 other 4th

generation 

assays and 

2 3rd

generation 

assays, WB, 

p24 Ag, and 

PCR 

confirmation

100% 1,005 uninfected10 other 

4th generation assays 

and 2 

3rd generation assays

99.9% 

initially 

reactive, 

100% 

repeatedly 

reactive

None

AxSYM HIV 

Ag/Ab Combo

Abbott 

Laboratories

Bourlet et 

al. 2005136

Clinical 1,443 2 other 

assays plus 

confirmation

100% 1,443 2 other 

assays

99.65% None

Kwon et al. 

2006149

Analytic 149 infected Known 

samples

100% 412 uninfectedKnown 

samples

98.0% None
383

Virus/ Type Test Trade 

Name

Manufacturer Cite Study Type Sensitivity Specificity Data Loss Comments

Samples Reference Sensitivity Samples Reference Specificity

Ly et al. 

2007156

Analytic 669 infected Known 

samples 

characterize

d genetically 

or by p24 Ag 

or WB

100% 1,005 uninfected8 screening 

assays, or 

WB negative 

or indeterminate and 

p24 Ag 

negative

99.8% 

initially 

reactive, 

same for 

repeatedly 

reactive

None

Sickinger 

et al. 

2007163

Analytic 453 infected Known 

samples

100% 1,938 

(hospitalized 

patients)

RNA and 

“marker” 

negative

99.90% None

7,900 

(blood 

donors)

RNA and 

“marker” 

negative

99.87% None

COBAS Core 

HIV Combi

Roche 

Diagnostics

Ly et al. 

2007154

Analytic 669 infected 10 other 4th

generation 

assays and 

2 3rd generation assays, 

WB, p24 Ag, 

and PCR 

confirmation

100% 1,005 uninfected10 other 4th

generation 

assays and 

2 3rd

generation 

assays

99.3% 

initially 

reactive, 

99.4% 

repeatedly 

reactive

None

Weber et 

al. 2002170

Analytic 1,641 

infected

WB, p24 Ag, 

RNA assay

100% 

(99.82% to 

100%)

10,031 

negative 

(including 

interference)

Other 

screening 

assays 

all negative, 

or WB 

negative, or 

WB 

indeterminate and 

p24 Ag 

negative

99.73% 

(99.61% to 

99.82%)

None

Coulter HIV-1 

p24 Antigen 

Assay

Coulter 

Corporation

- - - - - - - - -
384

Virus/ Type Test Trade 

Name

Manufacturer Cite Study Type Sensitivity Specificity Data Loss Comments

Samples Reference Sensitivity Samples Reference Specificity

Enzygnost 

HIV Integral II

Siemens 

Healthcare 

Diagnostics

- - - - - - - - -

Genscreen 

Plus HIV 

Ag/Ab Combo

Bio-Rad 

Laboratories

Aghokeng 

et al. 

2004131

Clinical 503 Another EIA, 

1 discriminatory assay, 2 

confirmatory 

assays

100% 

(99.6% to 

100%)

503 Another EIA, 

1 discriminatory assay, 2 

confirmatory 

assays

95%, or

82.5% 

(79.2% to 

85.8%) with 

indeterminate 

samples 

included

None when 

indeterminate 

samples 

included. 

8.4% (42) of 

the samples 

were indeterminate.

Ly et al. 

2007156

Analytic 669 infected Known 

samples 

characterized 

genetically 

or by p24 Ag 

or WB

100% 1,005 uninfected8 screening 

assays, or 

WB negative 

or indeterminate and 

p24 Ag 

negative

99.9% initial, 

99.9% 

repeat

None

Genscreen 

HIV Ultra AgAb Assay

Bio-Rad 

Laboratories

Ly et al. 

2007154

Analytic 669 infected 10 other 

4th generation assays 

and 2 

3rd generation assays 

and PCR

100% 1,005 uninfected10 other 

4th generation assays 

and 2 

3rd generation assays

99.7% 

initially 

reactive, 

99.8% 

repeatedly 

reactive

None

Modular HIV 

Combi

Roche 

Diagnostics

- - - - - - - - -

Murex HIV 

Ag/Ab Combo

Abbott 

Laboratories

Ly et al. 

2007156

Analytic 669 infected Known 

samples 

characterize

d genetically 

or by p24 Ag 

or WB

100% 1,005 uninfected8 screening 

assays, or 

WB negative 

or indeterminate and 

p24 Ag 

negative

99.5% 

initially 

reactive, 

99.6% for 

repeatedly 

reactive

None
385

Virus/ Type Test Trade 

Name

Manufacturer Cite Study Type Sensitivity Specificity Data Loss Comments

Samples Reference Sensitivity Samples Reference Specificity

VIDAS DUO 

QUICK

bioMerieux 

Clinical 

Diagnostics

- - - - - - - - -

VIDAS DUO 

ULTRA

bioMerieux 

Clinical 

Diagnostics

Bourlet et 

al. 2005136

Clinical 1,443 2 other 

assays plus 

confirmation 

tests

100% 1,443 2 other 

assays

99.86% None

Ly et al. 

2007154

Analytic 669 infected 10 other 4th

generation 

assays and 

2 3rd

generation 

assays and 

PCR

100% 1,005 uninfected10 other 

4th generation assays 

and 2 

3rd generation assays

98.8% initial, 

99.5% 

repeatedly 

reactive

None

Saville et 

al. 2001161

Clinical 2,773 Antibody 

screening, 

p24 Ag, 

confirmatory 

assays, NAT

100% 2,773 Antibody 

screening, 

p24 Ag, 

confirmatory 

assays, NAT

99.5% 0.1% 

(3 samples) 

excluded be 

because 

not “fully 

resolved.”

Vironostika 

HIV Uni-Form 

II Ag/Ab

bioMerieux 

Clinical 

Diagnostics

Aboud et 

al. 2006130

Clinical 1,380 Another EIA 

and 

confirmation

100% 

(98.8% to 

100%)

1,380 Another EIA 99.4% 

(98.8% to 

99.8%)

None

Iqbal et al. 

2005143

Clinical 264 WB 100% (100% 

to 100%)

264 WB 99.3% 

(97.8% to 

100%)

0.4% 

(1 sample) 

excluded for 

being 

indeterminate

Iqbal et al. 

2005143

Analytic 104 infected WB 100% 100 uninfectedWB 100% None This set not 

included in 

GRADE 

assessment 

(clinical set 

above 

included 

instead)
386

Virus/ Type Test Trade 

Name

Manufacturer Cite Study Type Sensitivity Specificity Data Loss Comments

Samples Reference Sensitivity Samples Reference Specificity

Ly et al. 

2007156

Analytic 669 infected Known 

samples 

characterize

d genetically 

or by p24 Ag 

or WB

100% 1,005 uninfected8 screening 

assays, or 

WB negative 

or indeterminate and 

p24 Ag 

negative

97.21% 

initially 

reactive, 

99.6% for 

repeatedly 

reactive

None

Seyoum et 

al. 2005162

Clinical 408 NAT and 

ExaVir Load 

test

100% 408 NAT and 

ExaVir Load 

test

99.2% None

HCV 4th

generation 

EIA

INNOTEST 

HCV Ab IV

Innogenetics 

NV

- - - - - - - - -

Monolisa HCV 

Ag/Ab Ultra 

Bio-Rad 

Laboratories

- - - - - - - - -

Murex 4.0 Abbott 

Laboratories

- - - - - - - - -
387

Table 56. GRADE Table for Question 5: Diagnostic Performance (Sensitivity/Specificity)

Virus Test Trade Name Manufacturer Quantity and 

Type of 

Evidence

Findings (Point 

Estimates)

Starting 

GRADE 

(Study 

Design

Table 49)

Decrease GRADE GRADE for 

Evidence for 

Outcome

Quality (Table 49)ConsistencyDirectnessPrecisionPublication Bias

Tests currently in use in U.S. Organ Procurement Organization (OPO): Immunoassays

HIV

3rd generation 

EIA

Genetics System 

(GS) HIV-1/HIV-2 

Plus 0 EIA

Bio-Rad 

Laboratories

1 A*159 Sensitivity: 99.8%A**

Specificity: 99.4%A

Main limitations: lack of 

diagnostic uncertainty, 

no blinding

Moderate -1 0 0 0 0 Low

HIVAB HIV-1/HIV-2 

(rDNA) EIA

Abbott 

Laboratories

2 A134,159 Sensitivity: 99.4%A159 and 

100%A134

Specificity: 97.7%A159 and 

99.74%A134

Main limitations: lack of 

diagnostic uncertainty, no 

blinding.

Study design and quality 

assessment equal for the 

two studies.

Moderate -1 0 0 0 0 Low

HBV (HBsAg; 

the surface 

antigen)

Abbott AxSYM 

HBsAg Assay

Abbott 

Laboratories

1 CDx†140 Sensitivity: 100%C‡

Specificity: 99.4%C

Main limitation: no blinding

High -1 0 0 0 0 Moderate

Abbott PRISM 

HBsAg

Abbott 

Laboratories

No studies - - - - - - - -
388

Virus Test Trade Name Manufacturer Quantity and 

Type of 

Evidence

Findings (Point 

Estimates)

Starting 

GRADE 

(Study 

Design

Table 49)

Decrease GRADE GRADE for 

Evidence for 

Outcome

Quality (Table 49)ConsistencyDirectnessPrecisionPublication Bias

ADVIA Centaur 

HBsAg Assay

Siemens 

Healthcare 

Diagnostics

1 A142 Sensitivity: 100%A

Specificity: 97.9%A

Main limitations: lack of 

diagnostic uncertainty, 

no blinding 

Moderate -1 0 0 0 0 Low

Genetic Systems 

(GS) HBsAg EIA 3.0

Bio-Rad 

Laboratories

No studies - - - - - - - -

HBV 

(anti-HBs; 

antibodies to 

the surface 

antigen)

Ortho Antibody to 

HBsAg ELISA Test 

System 3

Ortho Clinical 

Diagnostics

No studies - - - - - - - -

HBV 

(anti-HBc; 

antibodies to 

the core 

antigen)

Abbott PRISM 

HBcore

Abbott 

Laboratories

No studies - - - - - - - -

ADVIA Centaur HBc 

Total Assay

Siemens 

Healthcare 

Diagnostics

No studies - - - - - - - -

AxSYM Core 2.0 Abbott 

Laboratories

No studies - - - - - - - -

CORZYME Abbott 

Laboratories

No studies - - - - - - - -

Ortho HBc ELISA 

Test System 

Ortho Clinical 

Diagnostics

No studies - - - - - - - -
389

Virus Test Trade Name Manufacturer Quantity and 

Type of 

Evidence

Findings (Point 

Estimates)

Starting 

GRADE 

(Study 

Design

Table 49)

Decrease GRADE GRADE for 

Evidence for 

Outcome

Quality (Table 49)ConsistencyDirectnessPrecisionPublication Bias

HCV Abbott HCV EIA 2.0 Abbott 

Laboratories

3 CDx132,152,153 Sensitivity: 73.2%C132, 

85.7%C153, 100%C152

Specificity: 92.7%C152, 

99.8%C153, 99.9%C132

Main limitations: one study 

less appropriate reference 

standard, no blinding in 

any.

Anderson et al.132 used a 

less reliable reference 

standard. All other factors 

in study design and 

limitations assessment the 

same for all three studies.

High -1 0 0 0 0 Moderate

ADVIA Centaur HCV 

assay 

Siemens 

Healthcare 

Diagnostics

1 A139

1 DxC146

Sensitivity: Both 100%

Specificity: 94.4%C146, 

99.9%A139

Main limitations: one study 

suboptimal enrollment 

methods, no blinding in 

either.

Denoyel et al.139 did not 

report appropriate 

enrollment methods. 

All other study design and 

limitations assessments 

were the same.

High -1 0 0 0 0 Moderate

AxSYM Anti-HCV Abbott 

Laboratories

No studies - - - - - - - -
390

Virus Test Trade Name Manufacturer Quantity and 

Type of 

Evidence

Findings (Point 

Estimates)

Starting 

GRADE 

(Study 

Design

Table 49)

Decrease GRADE GRADE for 

Evidence for 

Outcome

Quality (Table 49)ConsistencyDirectnessPrecisionPublication Bias

Ortho HCV 

Version 3.0 ELISA 

Test System

Ortho Clinical 

Diagnostics

2 CDx146,167

1 A168

Sensitivity: All three 100%C

Specificity: 95.5%C146, 

99.7%C167, 99.9%A168

Main limitations: one study 

lack of diagnostic 

uncertainty, one study 

suboptimal enrollment 

methods, no blinding.

Vrielink et al.168 did not use 

samples with diagnostic 

uncertainty or report 

adequate enrollment 

methods. The rest of the 

study design and limitations 

assessment factors were 

the same for all three 

studies.

High -1 0 0 0 0 Moderate
391

Virus Test Trade Name Manufacturer Quantity and 

Type of 

Evidence

Findings (Point 

Estimates)

Starting 

GRADE 

(Study 

Design

Table 49)

Decrease GRADE GRADE for 

Evidence for 

Outcome

Quality (Table 49)ConsistencyDirectnessPrecisionPublication Bias

Tests currently in use in U.S. Organ Procurement Organization (OPO): NAT

HIV NAT COBAS AmpliScreen 

HIV-1 Test v. 1.5

Roche 

Diagnostics

1 DxC133

1 A159

Sensitivity: 7.7%C133 and 

92.6%A159

Specificity: 96.9%A159 and 

100%C133

Main limitations: one study 

inappropriate reference 

standard, other lack of 

diagnostic uncertainty, 

neither blinded

The main difference in 

findings appears to be due 

to the use of a reference 

standard inappropriate to 

calculate sensitivity in 

Bamaga et al.133

Moderate -1 0 0 0 0 Low

HCV NAT COBAS AmpliScreen 

HCV Test version. 

2.0

Roche 

Diagnostics

1 CDx133 Sensitivity: 20%C

Specificity: 99.4%C

Main limitations: 

inappropriate reference 

standards, no blinding

Moderate -1 0 0 0 0 Low

HBV NAT COBAS AmpliScreen 

HBV Test

Roche 

Diagnostics

1 CDx147 Sensitivity: 84.8%C

Specificity: 100%C

Main limitations: 

no blinding, potential for 

publication bias

Moderate -1 0 0 0 -1 Very Low
392

Virus Test Trade Name Manufacturer Quantity and 

Type of 

Evidence

Findings (Point 

Estimates)

Starting 

GRADE 

(Study 

Design

Table 49)

Decrease GRADE GRADE for 

Evidence for 

Outcome

Quality (Table 49)ConsistencyDirectnessPrecisionPublication Bias

HCV and 

HIV-1 NAT

ProCleix HIV-1/ 

HCV Assay

Gen-Probe 

Incorporated

1 CDx144

1 A128

HIV

Sensitivity: 99.9%A128 and 

100%C144

Specificity: 99.67%A128 and 

100%C144

HCV

Sensitivity: 99.3%C144 and 

99.6%A128

Specificity: 97.4%C144 and 

99.6%A128

Main limitations: one study 

lack of diagnostic 

uncertainty, one study 

no blinding, potential for 

publication bias.

Vargo et al.128 did not have 

diagnostic uncertainty, and 

Jackson et al. did not have 

blinding. The studies were 

on the same for the rest of 

the study design and 

limitations assessment 

factors.

Moderate 0 0 0 0 -1 Low
393

Virus Test Trade Name Manufacturer Quantity and 

Type of 

Evidence

Findings (Point 

Estimates)

Starting 

GRADE 

(Study 

Design

Table 49)

Decrease GRADE GRADE for 

Evidence for 

Outcome

Quality (Table 49)ConsistencyDirectnessPrecisionPublication Bias

Tests currently not in use in U.S. Organ Procurement Organization (OPO): 4th generation Immunoassays

HIV 

4th generation

ARCHITECT HIV 

Combo

Abbott 

Laboratories

2 A149,154 Sensitivity: Both 100%A

Specificity: 99.6%A149 and 

100%A154

Main limitations: lack of 

diagnostic uncertainty, 

suboptimal enrollment 

methods, no blinding.

The study design and 

limitations assessments 

were the same for both 

studies.

Moderate -1 0 0 0 0 Low
394

Virus Test Trade Name Manufacturer Quantity and 

Type of 

Evidence

Findings (Point 

Estimates)

Starting 

GRADE 

(Study 

Design

Table 49)

Decrease GRADE GRADE for 

Evidence for 

Outcome

Quality (Table 49)ConsistencyDirectnessPrecisionPublication Bias

AxSYM HIV Ag/Ab 

Combo

Abbott 

Laboratories

1 CDx136

3 A149,156,163

Sensitivity: All 100%

Specificity: 98%A,149

99.65%C,136 99.8%A,156

99.9%/99.87%A163 (last two 

from same study, different 

data sets)

Main limitations: two 

studies lack of diagnostic 

uncertainty and/or 

suboptimal enrollment 

methods, all studies no 

blinding.

Bourlet et al.136 had 

diagnostic uncertainty and 

appropriate enrollment 

methods while the rest did 

not. The studies were the 

same on all other study 

design and limitations 

assessment factors.

Moderate -1 0 0 0 0 Low
395

Virus Test Trade Name Manufacturer Quantity and 

Type of 

Evidence

Findings (Point 

Estimates)

Starting 

GRADE 

(Study 

Design

Table 49)

Decrease GRADE GRADE for 

Evidence for 

Outcome

Quality (Table 49)ConsistencyDirectnessPrecisionPublication Bias

COBAS Core HIV 

Combi

Roche 

Diagnostics

2 A154,170 Sensitivity: Both 100%A 

Specificity: 99.3%A154 and 

99.73%A170

Main limitations: lack of 

diagnostic uncertainty, 

one study suboptimal 

enrollment methods, 

both no blinding.

The two studies were the 

same for study design and 

limitations assessment.

Moderate -1 0 0 0 0 Low

Coulter HIV-1 p24 

Antigen Assay

Coulter 

Corporation

No studies - - - - - - - -

Enzygnost HIV 

Integral II

Siemens 

Healthcare 

Diagnostics

No studies - - - - - - - -
396

Virus Test Trade Name Manufacturer Quantity and 

Type of 

Evidence

Findings (Point 

Estimates)

Starting 

GRADE 

(Study 

Design

Table 49)

Decrease GRADE GRADE for 

Evidence for 

Outcome

Quality (Table 49)ConsistencyDirectnessPrecisionPublication Bias

Genscreen Plus HIV 

Ag/Ab Combo

Bio-Rad 

Laboratories

1 DxC131

1A156

Sensitivity: Both 100%

Specificity: 82.5%C,131

99.9%A156

Main limitations: One study 

lack of diagnostic 

uncertainty, one suboptimal 

enrollment methods, 

neither blinded.

Ly et al.156 did not have 

diagnostic uncertainty or 

report appropriate 

enrollment methods. 

All other study design and 

limitation assessment 

factors were the same.

High -1 0 0 0 0 Moderate

Genscreen HIV Ultra 

Ag-Ab Assay

Bio-Rad 

Laboratories

1 A154 Sensitivity:100%A

Specificity: 99.8%A

Main limitations: lack of 

diagnostic uncertainty, 

suboptimal enrollment 

methods, blinding 

Moderate -1 0 0 0 0 Low

Modular HIV Combi Roche 

Diagnostics

No studies - - - - - - - -
397

Virus Test Trade Name Manufacturer Quantity and 

Type of 

Evidence

Findings (Point 

Estimates)

Starting 

GRADE 

(Study 

Design

Table 49)

Decrease GRADE GRADE for 

Evidence for 

Outcome

Quality (Table 49)ConsistencyDirectnessPrecisionPublication Bias

Murex HIV Ag/Ab 

Combo

Abbott 

Laboratories

1 A154 Sensitivity: 100%A

Specificity: 99.6%A

Main limitations: lack of 

diagnostic uncertainty, 

suboptimal enrollment 

methods, blinding

Moderate -1 0 0 0 0 Low

VIDAS DUO QUICK bioMerieux 

Clinical 

Diagnostics

No studies - - - - - - - -

VIDAS DUO ULTRA bioMerieux 

Clinical 

Diagnostics

2 DxC136,161

1 A154

Sensitivity: All 100% 

Specificity:99.5%C,154

99.5%A,161 99.86%C136

Main limitations: one study 

lack of diagnostic 

uncertainty, one study 

suboptimal enrollment 

methods, two studies lack 

of blinding

Ly et al.154 did not have 

diagnostic uncertainty or 

report appropriate 

enrollment methods. None 

of the studies besides 

Saville et al.161 used 

blinding. All other study 

design and limitation 

assessment factors were 

the same.

High -1 0 0 0 0 Moderate
398

Virus Test Trade Name Manufacturer Quantity and 

Type of 

Evidence

Findings (Point 

Estimates)

Starting 

GRADE 

(Study 

Design

Table 49)

Decrease GRADE GRADE for 

Evidence for 

Outcome

Quality (Table 49)ConsistencyDirectnessPrecisionPublication Bias

Vironostika HIV 

Uni-Form II Ag/Ab

bioMerieux 

Clinical 

Diagnostics

3 CDx130,143,162

1 A156

Sensitivity: All 100%

Specificity: 99.2%C,

162

99.3%C,143 99.4%C,130

99.6%A156

Main limitations: one study 

lack of diagnostic 

uncertainty, no blinding

Ly et al.156 did not have 

diagnostic uncertainty or 

report appropriate 

enrollment methods. 

All other study design and 

limitation assessment 

factors were the same.

High -1 0 0 0 0 Moderate

HCV

4th generation

INNOTEST HCV Ab 

IV

Innogenetics 

NV

No studies - - - - - - - -

Monolisa HCV Ag/Ab 

Ultra

Bio-Rad 

Laboratories

No studies - - - - - - - -

Murex 4.0 Abbott 

Laboratories

No studies - - - - - - - -

* A: Analytic study

** A: Analytic sensitivity/specificity

† CDx: Clinical diagnostic cohort

‡ C: Clinical sensitivity/specificity
399

Evidence Reviews: III. Donor interventions to decrease 

transmission of HIV, HBV,or HCV from infected donors

Question 6. Which donor interventions reduce the probability of 

pathogen transmission from an organ donor infected with HIV, HBV, or 

HCV to a previously uninfected recipient?

Two publications of the same study of virus inactivation in organs met the inclusion criteria.200,201

The study described kidney perfusion techniques that may potentially inactivate hepatitis C. The study 

methods and results are shown in Table 57 and Table 58, respectively. The study procured kidneys from 

HCV positive deceased donors, and investigated the virus-reducing capacity of four inactivation 

protocols:

• The first (called “standard” by the authors) involved initial flushing with 1.0L of University of 

Wisconsin (U/W) solution, 20 hours of pulsatile perfusion, and another U/W flushing. 

U/W solution is “a normokalemic, intracellular colloid injected into vital organs during 

harvesting to preserve function before transplantation”.

202

• The second (called “enhanced”) involved a second pulsatile perfusion and additional flushings. 

• The third involved 24 hours of pulsatile perfusion at a lower flow rate

• The fourth (“ultrafiltered”) involved the filtration of used perfusate during the perfusion process.

The results (Table 58) showed that all four methods substantially reduced the viral load. The best results

were found with the enhanced pulsatile perfusion, for which 99.7% of the HCV viral particles had been

removed within 15 minutes after the start of the second perfusion.

Regarding study quality (Table 59), there was no control group that did not receive inactivation; no 

“patients” were actually enrolled. Applying the GRADE system (Table 60) resulted in a grade of Low. 

This was based on the fact that it was only a single study, and there was no non-inactivated control group,

but it did find a large magnitude of effect as well as a dose response association.
400

Table 57. Inactivation Methods in Zucker et al. (1994)

Kidney Donor

Inactivation 

Procedure Procedural Steps

Donor 1, Deceased 

HCV positive

Standard pulsatile 

perfusion

1) Flushed with 1.0 L of U/W solution

2) 20 hours of perfusion on a Waters MOX-9 pulsatile 

perfusion apparatus using 1.0 L of silica gel-treated 

plasma at between 4-6 degrees Celsius at a flow 

rate of approximately 400mL/minute 

3) Again flushed with 1.0 L of U/W solution

Donor 2, Deceased 

HCV positive

Enhanced pulsatile 

perfusion

Steps 1-2 of the standard procedure, and then:

3) Three additional flushes with 1.0 L of U/W solution

4) Another 20 hours of perfusion using 1.0 L of silica 

gel-treated plasma at between 4-6 degrees Celsius 

at a flow rate of approximately 400mL/minute 

5) Again flushed with 1.0 L of U/W solution

Donor 3, Deceased 

HCV positive, 

Kidney 1

Pulsatile perfusion, 

without ultrafiltration 

of perfusate

1) Flushed with 1.0 L of U/W solution

2) 24 hours of perfusion on a Waters MOX-9 pulsatile 

perfusion apparatus using 1.0 L of silica gel-treated 

plasma at between 6 degrees Celsius at a flow rate 

of 200mL/minute

Donor 3, Deceased 

HCV positive, 

Kidney 2

Pulsatile perfusion, 

with ultrafiltration of 

perfusate

1) Flushed with 1.0 L of U/W solution

2) 24 hours of perfusion on a Waters MOX-9 pulsatile 

perfusion apparatus using 1.0 L of silica gel-treated 

plasma at between 6 degrees Celsius at a flow rate 

of 200mL/minute, with ultrafiltration of perfusate 

using a high-flow hollow-fiber filter with a molecular 

weight cut-off of 300k daltons
401

Table 58. Inactivation Results in Zucker et al. (1994)

Total 

Viral Burden 

BEFORE 

Inactivation When the Viral Load was Measured

Total 

Viral Burden 

AFTER 

Inactivation

% of 

Viral Copies 

that had been 

Removed

Standard Pulsatile Renal Preservation Procedure

4.78 x 105 After the first 4 hours of pulsatile perfusion 1.28 x 105 73%

Enhanced Pulsatile Renal Preservation Procedure

247 x 105 After the full 20 hours of the first pulsatile perfusion 60.5 x 105 76%

247 x 105 After the 3 additional U/W flushes and 15 minutes 

after the start of the second pulsatile perfusion

0.74 x 105 99.7%

Pulsatile Renal Preservation Procedure, without Ultrafiltration of Perfusate

160 x 105 After the first 1 hour of pulsatile perfusion 120 x 105 25%

160 x 105 After the full 24 hours of pulsatile perfusion 50 x 105 69%

Pulsatile Renal Preservation Procedure, with Ultrafiltration of Perfusate

160 x 105 After the first 1 hour of ultrafiltered pulsatile perfusion 60 x 105 63%

160 x 105 After the full 24 hours of ultrafiltered pulsatile 

perfusion

15 x 105 91%

Table 59. Question 6: Quality Assessment

Study 6a 6b 6c 6d 6e 6f 6g 6h

Zucker et al. (1994)200,201  

A checkmark () means that the study met the quality criterion for this Question; the lack of a checkmark means that 

the study either did not meet the criterion, or it was unclear whether the study met the criterion. The criteria specific to 

this Question were: 

6a. Were the patients randomly assigned to treatments?

6b. Was the study planned prospectively (i.e., before any data were collected)

6c. Were all consecutive patients enrolled (or a random sample of eligible patients)?

6d. Were the two groups comparable at baseline? (age, sex, comorbidities, indication for transplant, 

previous duration on waitlist)

6e. If not, were statistical adjustments performed to control for baseline differences? 

6f. Were the two groups treated concurrently?

6g. Did at least 85% of the study enrollees provide data?

6h. Was the between-group difference in study completion rates less than 15%?
402

Table 60. GRADE Table for Question 6 (Inactivation)

Comparison Outcome

Quantity and 

Type of 

Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE of 

Evidence for 

Study QualityConsist

Outcome

ency

Directness

Precision

Publication BiasLarge MagnitudeDose ResponseConfounders would reduce the effect

Inactivating vs. 

not inactivating 

pathogens in 

solid organs

Viral 

burden

One study200,201 The four 

inactivation 

procedures 

reduced viral 

burden 69%% 

to 99.7% 

Low -1 -1 0 0 0 +1 +1 0 Low
403

Evidence Reviews: IV. Potential risks and benefits of 

transplanting, or not transplanting, solid organs from donors

positive for HIV, HBV, or HCV

Question 7. How do the clinical outcomes of recipients of organs from 

donors infected with HIV, HBV, or HCV compare to those who remain on 

the transplant list?

This question involves whether the long-term health of a recipient will be better if 1) an organ from a 

known infected donor is transplanted, or 2) the patient remains on the waiting list for an organ from an 

uninfected donor. Transplanting an organ from an infected donor incurs the chance of a new infection, in 

addition to the usual risks of organ transplantation (e.g., graft failure, graft-vs. host disease). However, 

remaining on the waiting list also entails risks, primarily the risk of death before an organ becomes 

available. Even if an organ from an uninfected donor become available, transplantation procedural risks 

will still apply, and these risks would be slightly higher at that time because the recipient would be older.

This question should not be confused with Question 8, which considers clinical outcomes after the 

transplantation of organs from at-risk donors with unknown infection status.

Our original inclusion criteria for this question (Table 2) required a waitlist control group; only one study 

met those original criteria: Abbott et al. (2004).82 This study involved the transplantation of kidneys from 

deceased donors known to have been infected with HCV; its methods and results are detailed in the next 

section. Due to the paucity of evidence, we relaxed the initial inclusion criteria to include:

• Studies of recipients who were negative before transplant that compared the clinical outcomes 

after receiving an organ from a positive donor vs. receiving an organ from a negative donor

• Studies of recipients who were positive before transplant that compared clinical outcomes after 

receiving an organ from a positive donor vs. receiving an organ from a negative donor

This expansion yielded 7 and 22 additional publications, respectively; they are listed in Table 64. 

Although these comparisons do not involve the waitlist, they are still relevant. When a potential organ 

recipient does not receive an organ because it is from a known positive donor, the recipient remains on 

the waitlist for an organ from a negative donor. This hoped-for organ may or may not become available 

before the patient dies. The comparison group “receiving an organ from a negative donor” represents the 

realization of this hope, so it estimates a relatively good waitlist outcome.

The use of organs from infected donors may be more acceptable for recipients who are already positive 

before transplant, because disease transmission is less important (although dual infection with a different 

genotpye is possible). Their outcomes may be quite different from the outcomes of recipients who were 

negative before transplant, which is why we considered the two types of recipients separately.

Some centers may reserve organs from infected donors only for the most ill recipients. For example, 

Haji et al. (2004)77 stated that “at our institution, an HCV-seropositive donor was used when, in the 

judgment of the transplant team, the recipient was critically ill and not a candidate for mechanical 
404

ventricular assist device or had a significant complication while on the ventricular assist device.”77

(page 278) Based on this practice, a simple comparison of survival times between those who received 

organs from infected donors and those who received organs from uninfected donors would be biased 

against the former group. Thus, a better analysis would attempt to control for pre-transplant differences so 

that the comparison is more balanced.

Organs from Positive Donors Compared to Remaining on the Waitlist

Abbott et al. (2004)82 considered the clinical scenario of a patient with end-stage renal disease (ESRD) on 

dialysis, and a kidney from a deceased HCV+ donor becomes available to this patient. Authors used 

retrospective data on Medicare beneficiaries in the United States Renal Data System who had been on the 

kidney transplant waiting list between 4/1/1995 and 7/31/2000. Of the 38,270 potential recipients:

• 389 patients (1%) were transplanted with kidneys from deceased HCV+ donors (abbreviated 

DHCV+). Of these 389 recipients, 201 of them (52%) were HCV+ before the transplant.

• 16,106 patients (42%) were transplanted with kidneys from deceased HCV- donors. Of these 

recipients, 508 of them (3%) were HCV+ before the transplant.

• 17,044 patients (45%) were not transplanted during the study period. The pre-transplant HCV 

status of these recipients was not reported.

• 4,731 patients (12%) were transplanted prior to dialysis, or transplanted with an organ other than 

a kidney, or transplanted with any kidney from a living donor (neither separate counts not 

outcome data were reported for these patients). The pre-transplant HCV status of these recipients 

was not reported.

A critical question is whether these groups of patients were similar before the transplantations occurred. 

If they were not, then pre-transplant factors (e.g., age, or amount of time already on waitlist) could 

explain subsequent differences in mortality rates. In this study, there were some differences between 

the 389 patients who received kidneys from DHCV+ and the full group of patients (all reported 

characteristics are listed in Table 61 below). The only characteristic with a particularly large difference 

at baseline involved race: 58% of recipients of organs from DHCV+ donors were African-American, 

as compared to only 30.4% of the full group of enrolled patients. Several of the other differences were 

statistically significant (due to the extremely large number of enrolled patients), but the actual size of the 

baseline differences were not generally large. 

The authors performed adjusted analyses to control for pre-transplant differences. Any variable that was 

statistically significantly associated with mortality (defined as p <0.10) was adjusted for: recipient age, 

recipient race, cause of end-stage renal disease (ESRD), year of first dialysis, presence of congestive heart 

failure, ischemic heart disease, peripheral vascular disease, serum albumin level, Medicare claims for 

access-related complications, and Medicare HCV claims at the time of listing. 

The mortality analyses contained an important limitation: if an organ from any donor other than a 

deceased HCV+ donor was transplanted, all subsequent survival times were excluded from the analysis. 

Therefore, the mortality from remaining on the waitlist was only up to the point of receiving an alternate 

kidney. A more comprehensive approach would have included post-transplant survival times for those 

who did eventually receive kidneys from alternate donors.
405

Authors compared the adjusted mortality rates of kidney recipients from a DHCV+ donor to waitlist 

patients. The reported results are shown in Figure 11. The adjusted hazard ratio of 0.76 (95% confidence

interval 0.60 to 0.96) indicated reduced mortality after receiving a kidney from a deceased HCV+ donor 

as compared to being on the waitlist. 

Authors did not directly compare the mortality rates of recipients of kidneys from HCV+ donors to 

recipients of kidneys from HCV- donors. However, they did report a comparison between receiving a 

kidney from any deceased donor (regardless of donor HCV status) and being on the waitlist. This 

comparison favored transplantation substantially (adjusted hazard ratio of 0.47; 95% CI: 0.43 to 0.50). 

Thus, the mortality advantage of receiving a kidney more than doubled when recipients of HCV- donor 

kidneys were included in the analysis (i.e., the 24% mortality advantage in the primary analysis increased 

to a 53% advantage).

The GRADE evidence profile appears in Table 63. The grade was Very Low, which was due to three

factors: 1) the study did not randomly assign recipients to groups; 2) the study excluded survival data 

after the transplantation of any kidney that was not a kidney from a deceased HCV+ donor; and 

3) that there was only one study. If either of the latter two factors were removed, the rating would still be 

“Very Low”.
406

Table 61. Baseline Characteristics in the Abbott et al. (2004) Study

Characteristic

DHCV+

(N = 389)

Full Group of 

Enrolled Patients

(N = 38,270)

Between-group Difference in 

Percentage Points (p.p.), or Hedges’ g

% male 75.3% 61.3% 14 p.p.

% African-American 58.4% 30.4% 28 p.p.; Large difference at baseline

% with diabetes as the cause of endstage renal disease29.8% 35.3% 5 p.p.

% with hypertension 77% 73.9% 4 p.p.

% with congestive heart failure 15.9% 13.8% 2 p.p.

% ischemic heart disease 9.7% 8.9% 1 p.p.

% with smoking history 8.4% 5.3% 3 p.p.

% with hemodialysis (not peritoneal) 86.1% 80.5% 6 p.p.

% with peripheral vascular disease 4.4% 5.3% 1 p.p.

% with Medicare claims for HCV at the 

time of listing

5.4% 0.5% 5 p.p.

% with positive HCV serology by UNOS 51.7% Not reported Not calculable

% with Medicare claims for access 17.7% 14.2% 3.5 p.p.

Mean Age 51.2 (SD: 11.3) 47.6 (SD: 13.8) g = 0.26

Mean Body Mass Index 26.0 (SD: 5.5) 26.7 (SD: 6.2) g = 0.11

Mean Serum albumin (gm/dL) 3.2 (SD: 0.7) 3.4 (SD: 0.7) g = 0.29

Mean Hematocrit 28.2 (SD: 5.8) 27.9 (SD: 5.7) g = 0.05

Note: Shaded cells represent baseline characteristics that differed by 15+ percentage points, or differed by 0.4+ on the scale of Hedges’ g. 

Hedges’ g is the difference between means divided by the pooled standard deviation. The difference in percentage points, and values for Hedges’ g, were 

calculated by ECRI Institute

SD – Standard deviation
407

Figure 11. Adjusted Mortality Results of Transplanting Kidneys from DHCV+ Donors Compared to the Waitlist

0 0.5 1 1.5 2

Adjusted hazard ratio*

0.76

Note: The horizontal bars represent the reported 95% confidence interval around the adjusted hazard ratio. The fact that the confidence intervals was fully below 1.0 

indicates that the adjusted hazard ratio was statistically significantly in favor of receiving a kidney from a DHCV+ donor over being on the waitlist.

*Variables adjusted for included recipient age, recipient race, cause of end-stage renal disease, year of first dialysis, presence of congestive heart failure, 

ischemic heart disease, peripheral vascular disease, serum albumin level, and Medicare claims for access-related complications and Medicare claims for accessrelated complications HCV
408

Organs from Positive Donors Compared to Organs from Negative Donors When the 

Recipients were Negative Before Transplant

We included seven publications (five unique studies) that made this comparison. One study involved HBV, 

and four involved HCV. General study characteristics are listed in the upper portion of Table 64, and details 

of methods appear in the upper portion of Table 65.

Regarding quality (the upper portion of Table 67), none of the studies were randomized or prospective, but 

all five treated the groups concurrently, and three studies enrolled patients consecutively. Two studies 

reported data on at least 85% of the enrolled patients and also had less than a 15% difference in completion 

rates between groups. For baseline comparability of groups (upper portion of Table 66), only two of the five 

studies reported any specific characteristics to enable a comparison (the Fong et al. [2002]

55 study of HBV, 

and the Haji et al. [2004]

77,79 study of HCV). Our analyses of between-group comparability identified three 

large differences at baseline (identified as gray cells in the upper portions of Table 66). For Fong et al. 

(2002)55, the rate of donor death due to stroke was substantially higher in the D+ group (51% than the Dgroup (36%). For Haji et al. (2004)77,79, the percentage of donors who were male was greater in the D+ group 

(74%) than in the D- group (57%), and also the mean recipient age was greater in the D+ group (age 57) than 

in the D- group (age 52). 

One way to address the problem of differing pre-transplant characteristics is to perform statistical 

adjustments of the results. Only one of the five studies (Abbott et al. 2003)83,84 clearly performed such 

adjustments. The methods section of the Haji et al. (2004)77,79 study reported some use of Cox regression 

“to adjust for significant covariates”, but authors did not report whether the reported hazard ratio of 2.8 was 

adjusted or unadjusted.

All study results appear in the upper portion of Table 68, and pertinent plots are in Figure 12. The points

appear without confidence intervals because studies did not report enough information to permit such 

calculation, which is also why no meta-analyses of these results were possible. Note that in the figure, the 

data generally fall below the 45 degree line, suggesting shorter survival among those who received D+ 

organs than those who received D- organs. However, the lack of demonstrated group comparability, and the 

possibility that in some studies the pre-transplant prognosis was poorer for recipients of D+ organs, make it 

difficult to interpret these raw results. The one study that controlled for baseline differences (Abbott et al. 

2003)83,84) found a significantly shorter survival of those who received D+ organs (adjusted hazard ratio of 

2.25; see footnote to the figure). The Haji et al. (2004)77,79 study, which may have controlled for baseline 

differences, also reported shorter survival for recipients of D+ organs (see Table 68).

Regarding different genotypes of HBV and HCV, none of the five studies reported donors' genotypes, or 

stated whether recipient survival was different by donor genotype. 

The GRADE evidence profiles appear in Table 63. We graded the evidence as Very Low for all of these

evidence bases, except for the comparison of recipient survival of HCV+ and HCV- organs, which we 

graded as Low. None of these studies had randomized recipients to groups, and several had pre-transplant 

differences between groups that were not statistically adjusted for. The single “Low” GRADE (for recipient 

survival comparing HCV+ and HCV- donors) was due to the large effect magnitudes found in those three 

studies.
409

Figure 12. Clinical Outcomes of Negative Recipients: Positive vs. Negative Donors, 

any Pathogen, any Organ

0

10

20

30

40

50

60

70

80

90

100

0 10 20 30 40 50 60 70 80 90 100

Survival %

after D+ 

transplant

Survival %

after D- transplant

Graft survival of HBV- recipients after kidney transplant

Graft survival of HCV- recipients after liver transplant

Patient survival of HBV- recipients after kidney transplant

Patient survival of HCV- recipients after liver transplant

Patient survival of HCV- recipients after heart transplant

s

s

s

Note: The diagonal line represents no difference in survival between those who received an organ from a positive donor 

and those who received an organ from a negative donor. Points above the diagonal line favor recipients of organs 

from positive donors, whereas points below the diagonal line favor recipients of organs from negative donors. 

This figure only includes studies that reported graft or survival data as percentages, and it only includes the 

longest followup timepoint from each study. The full data are provided in Table 68. None of the plotted studies 

reported confidence intervals. Studies with a lower case ‘s’ next to the point reported that the comparison of full 

survival curves was statistically significant; all other studies either did not report whether the difference was 

statistically significant, or reported that the difference was not statistically significant. One of the studies did not 

report results on a percentage scale, and so its results do not appear in the plot. This was the Abbott et al. 

(2003)83,84 study, which found an adjusted hazard ratio of death of 2.25 (95% CI: 1.56 to 3.24) in favor of 

recipients of organs from HCV- donors.
410

Organs from Positive Donors Compared to Organs from Negative Donors When the 

Recipients were Positive Before Transplant

We included 22 publications (17 unique studies) that made this comparison. Three studies involved HBV 

only, 13 studies involved HCV only, and one study provided separate data on both HBV and HCV. General 

study characteristics are listed in the lower portion of Table 64, and details of methods appears in the lower 

portion of Table 65.

Regarding quality (the lower portion of Table 67), none of the studies were randomized or prospective, but 

all 17 treated the groups concurrently, and 13 studies enrolled patients consecutively. Ten studies reported 

data on at least 85% of the enrolled patients and also had less than a 15% difference in completion rates 

between groups.

For baseline comparability of groups, 10 of the 17 studies (two of HBV and eight of HCV) reported specific 

characteristics to enable a comparison. These 10 studies reported 128 characteristics that could be compared 

(listed in the lower portions of Table 66), and we classified 27 of these 128 were as large differences 

(reproduced below in Table 62). In the HBV studies, the differences involved rates of donor HCV 

(HBV+ donors were more likely to also be HCV+), donor and recipient age (both were higher in D+ groups), 

and race (D+ donors were more likely to be African-American and less likely to be Caucasian-American). 

In the HCV studies, we noticed two types of consistent differences: donor/recipient ages (which were higher 

in D+ groups) and the recipient’s amount of time on the waitlist (which was much shorter in the D+ groups: 

9.9 months vs. 17.7 months in Woodside et al. (2003)85, and 9 months vs. 29 months in Mandal et al. (2000).

86
411

Table 62. Large Pre-transplant Differences between Recipients of D+ and D- Organs in 

Studies of Pre-transplant Positive Recipients

Study Characteristic

Mean (SD) or 

% for 

Recipients 

of 

D+ Organs

Mean (SD) or 

% for 

Recipients of 

D- Organs

Difference in 

Percentage 

Points, or 

Hedges’ g

Recipients Infected Before Transplant; Comparison of Clinical Outcomes after HBV+ Donor vs. HBV- Donor

Fong et al. 

(2002)55

Donor % HCV+ 22%

(31/140)

5%

(105/2093)

17 p.p.

Recipient % African-American 56%

(78/140)

39%

(816/2093)

17 p.p.

Donor age 42.7

(SD: 13.9)

34.9

(SD: 18.2)

g = 0.43

Madayag et al. 

(1997)56

Recipient % Caucasian-American 26%

(12/45)

49%

(22/45)

23 p.p.

Recipient age 49.1

(SD: 11.8)

43.6

(SD: 11.8)

g = 0.47

Recipients Infected Before Transplant; Comparison of Clinical Outcomes after HCV+ Donor vs. HCV- Donor

Woodside et al. 

(2003)85 CMV % donor/recipient pairs with both CMV+

70%

(14/20)

55%

(11/20)

15 p.p.

Recipient % anti-HBc+ 20%

(4/20)

35%

(7/20)

15 p.p.

Recipient % Caucasian-American 15%

(3/20)

35%

(7/20)

20 p.p.

Recipient % Hispanic-American 35%

(7/20)

5%

(1/20)

30 p.p.

Recipient % male 80%

(16/20)

65%

(13/20)

15 p.p.

Recipient Triple drug therapy % 100%

(20/20)

80%

(16/20)

20 p.p.

Recipient time on waitlist (months) 9.9

(SD: 8)

17.7

(SD: 14.8)

g = 0.66
412

Study Characteristic

Mean (SD) or 

% for 

Recipients 

of 

D+ Organs

Mean (SD) or 

% for 

Recipients of 

D- Organs

Difference in 

Percentage 

Points, or 

Hedges’ g

Mandal et al. 

(2000)86

Donor % CMV+ 87%

(16/18)

50%

(5/10)

37 p.p.

Recipient % with diabetes 28%

(5/18)

10%

(1/10)

18 p.p.

Recipient % being retransplanted 28%

(5/18)

60%

(6/10)

32 p.p.

AB mismatch 3.2

(SD: 0.8)

2.3

(SD: 0.9)

g = 1.08

Cold ischemia time (hrs) 28

(SD: 8.5)

22

(SD: 9.5)

g = 0.68

Donor age 46

(SD: 8.5)

35

(SD: 19)

g = 0.84

DR mismatch 1.6

(SD: 0.8)

1.3

(SD: 0.3)

g = 0.45

Recipient age 48

(SD: 8.5)

44

(SD: 6.3)

g = 0.51

Recipient time on waitlist (months) 9

(SD: 12.7)

29

(SD: 9.5)

g = 1.71

Morales et al. 

(1995)87

Recipient % abnormal liver histology 31%

(7/24)

50%

(20/40)

19 p.p.

Recipient % anti-HBc+ 50%

(12/24)

23%

(9/40)

27 p.p.

Recipient % renal disease: chronic 

glomerulonephritis

55%

(13/24)

35%

(14/40)

20 p.p.

Recipient pre-transplant number of 

transfusions

7

(SD: 8)

21

(SD: 39)

g = 0.45

Salizzoni et al. 

(2001)88

Donor age 62.6

(SD: NR)

53.7

(SD: NR)

g = 0.49

Testa et al. 

(1998)89

Recipient % male 50%

(11/22)

73%

(84/115)

23 p.p.

Note: This table only includes pre-transplant differences that met our criteria for “large”, which was a Hedges’ g of 0.4 or 

more for continuous data, or a difference in percentage points of 15 or more. These differences were calculated 

by ECRI Institute. The full list of reported baseline characteristics is in Table 66.
413

One way to address the problem of differing pre-transplant characteristics is to perform statistical 

adjustments of the results. Only four of the 17 studies did this (Fong et al. [2002]

55, Madayag et al. [1997]56, 

Abbott et al. [2003]

83,84, and Marroquin et al. [2001]).90

All study results appear in the lower portion of Table 68, and pertinent plots are in Figure 13, Figure 14, and 

Figure 15. The points appear without confidence intervals because studies did not report enough information 

to permit such calculation; this also explains why no meta-analyses of these results were possible. The HBV 

plot (Figure 13) shows no consistent trend: two data points favored the D+ group, three data points favored 

the D- group, and four data points suggested equivalence. Restricting the analysis to the two HBV studies 

that used statistical adjustments to control for baseline prognosis, one study (Madayag et al. [1997]56) found 

poorer graft survival in the D+ group, and the other study (Fong et al. [2002]55) found no large differences in 

either graft survival or patient survival.

The two HCV plots (Figure 14 for kidney transplants, and Figure 15 for liver transplants) each suggest a 

small but consistently better survival for recipients of D+ organs than recipients of D- organs; one cannot 

determine the statistical significance of this effect due to insufficient reporting. Restricting the analysis to the 

two HCV studies that used statistical adjustments to control for baseline prognosis, they found conflicting 

results. Whereas Abbott et al. (2003)83,84 found shorter survival in the D+ group (adjusted hazard ratio 2.04), 

Marroquin et al. (2001)90 found longer survival in the D+ group (adjusted odds of patient survival at two 

years was 0.51) (results of these two studies are not plotted because the results were not reported as 

percentages; see the footnote to the figure).

Regarding different genotypes of HBV, none of the four studies reported donors' genotypes, or stated 

whether recipient survival different by donor genotype. For HCV genotypes, two studies88,91 attempted to 

investigate the impact of genotype, but they did not draw conclusions due to the paucity of data. A third 

study92 provided pre-tranpslant genotypes for all donors and recipients, as well which which genotype 

predominated for each donor-recipient pair. Recipient survival was unaffected by whether the predominant 

genotype was from the donor or was already present in the recipient. None of the other studies attempted 

analyses by HCV genotype.

GRADE Assessment of Clinical Outcomes After Receiving Organs from Infected Donors

The GRADE evidence profiles (HBV graft survival; HBV patient survival; HCV graft survival; and HCV 

patient survival) appear in Table 63. We graded the evidence as Very Low for all four pathogen/outcome

combinations, due to the lack of randomization to groups and the pre-transplant differences between groups.
414

Figure 13. Clinical Outcomes of Positive Recipients: Positive vs. Negative Donors, 

HBV, Kidney or Liver

0

10

20

30

40

50

60

70

80

90

100

0 10 20 30 40 50 60 70 80 90 100

Survival %

after D+ 

transplant

Survival %

after D- transplant

Graft survival of HBV+ recipients after kidney transplant

Graft survival of HBV+ recipients after liver transplant

Patient survival of HBV+ recipients after kidney transplant

Patient survival of HBV+ recipients after liver transplant

s

s

Note: The diagonal line represents no difference in survival between those who received an organ from a positive donor 

and those who received an organ from a negative donor. Points above the diagonal line favor recipients of organs 

from positive donors, whereas points below the diagonal line favor recipients of organs from negative donors. 

This figure only includes studies that reported graft or survival data as percentages, and it only includes the 

longest followup timepoint from each study. The full data are provided in Table 68. None of the plotted studies 

reported confidence intervals. Studies with a lower case ‘s’ next to the point reported that the comparison of full 

survival curves was statistically significant; all other studies either did not report whether the difference was 

statistically significant, or reported that the difference was not statistically significant.
415

Figure 14. Clinical Outcomes of Positive Recipients: Positive vs. Negative Donors, 

HCV, Kidney

0

10

20

30

40

50

60

70

80

90

100

0 10 20 30 40 50 60 70 80 90 100

Survival %

after D+ 

transplant

Survival %

after D- transplant

Graft survival of HCV+ recipients after kidney transplant

Patient survival of HCV+ recipients after kidney transplant

Note: The diagonal line represents no difference in survival between those who received an organ from a positive donor 

and those who received an organ from a negative donor. Points above the diagonal line favor recipients of organs 

from positive donors, whereas points below the diagonal line favor recipients of organs from negative donors. 

This figure only includes studies that reported graft or survival data as percentages, and it only includes the 

longest followup timepoint from each study. The full data are provided in Table 68. None of the plotted studies 

reported confidence intervals. Studies with a lower case ‘s’ next to the point reported that the comparison of full 

survival curves was statistically significant; all other studies either did not report whether the difference was 

statistically significant, or reported that the difference was not statistically significant. One of the studies did not 

report results on a percentage scale, and so its results do not appear in the plot. This was the Abbott et al. 

(2003)83,84 study, which found an adjusted hazard ratio of death of 2.04 (95% CI: 1.20 to 3.45) in favor of 

recipients of negative organs.
416

Figure 15. Clinical Outcomes of Positive Recipients: Positive vs. Negative Donors, 

HCV, Liver

0

10

20

30

40

50

60

70

80

90

100

0 10 20 30 40 50 60 70 80 90 100

Survival %

after D+ 

transplant

Survival %

after D- transplant

Graft survival of HCV+ recipients after liver transplant

Patient survival of HCV+ recipients after liver transplant

s

Note: The diagonal line represents no difference in survival between those who received an organ from a positive donor 

and those who received an organ from a negative donor. Points above the diagonal line favor recipients of organs 

from positive donors, whereas points below the diagonal line favor recipients of organs from negative donors. 

This figure only includes studies that reported graft or survival data as percentages, and it only includes the 

longest followup timepoint from each study. The full data are provided in Table 68. None of the plotted studies 

reported confidence intervals around the data. Studies with a lower case ‘s’ next to the point reported that the 

comparison of full survival curves was statistically significant; all other studies either did not report whether the 

difference was statistically significant, or reported that the difference was not statistically significant. One of the 

studies did not report results on a percentage scale, and so its results do not appear in the plot. These was the 

Marroquin et al. (2001)90 study, which found an adjusted two-year odds of graft failure of 0.88, in favor of 

recipients of positive organs, and an adjusted two-year odds of patient death of 0.51, also in favor of recipients of 

positive organs.
417

Table 63. GRADE Table for Question 7 (Clinical Outcomes of Known Positive Organs vs. Waitlist or 

Known Negative Organs)

Comparison Outcome

Quantity and 

Type of 

Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE of 

Evidence 

for 

Outcome

Overall

GRADE of

Evidence

Stu

Base

dy Quality

Consistency

Directness

Precision

Publication BiasLarge MagnitudeDose ResponseConfounders would reduce the effect

Receiving an HCV+ organ 

compared to remaining 

on the waitlist

Recipient 

survival

One 

observational 

study82

Adjusted hazard ratio 0.76

(95% CI: 0.6 to 0.96)

(in favor of transplantation 

over the waitlist)

Low -1 -1 0 0 0 0 0 0 Very Low Very Low

Receiving an HBV+ organ 

compared to receiving a 

negative organ for 

recipients who were 

NEGATIVE before 

transplant

Graft 

survival

One 

observational 

study55

Results favored receiving 

an organ from a negative 

donor:

1 year: D+ 87%, D- 88%

2 yrs.: D+ 78%, D- 83%

3 yrs: D+ 72%, D- 77%

Low -1 -1 0 0 0 0 0 0 Very Low

Very Low

Recipient 

survival

One 

observational 

study55

Results favored receiving 

an organ from a negative 

donor:

1 year: D+ 94%, D- 94%

2 yrs.: D+ 90%, D- 92%

3 yrs: D+ 86%, D- 90%

Low -1 -1 0 0 0 0 0 0 Very Low
418

Comparison Outcome

Quantity and 

Type of 

Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE of 

Evidence 

for 

Outcome

Overall

GRADE of

Evidence

Stu

Base

dy Quality

Consistency

Directness

Precision

Publication BiasLarge MagnitudeDose ResponseConfounders would reduce the effect

Receiving a HCV+ organ 

compared to receiving a 

negative organ for 

recipients who were 

NEGATIVE before 

transplant

Graft 

survival

Three 

observational 

studies 

16,83,84,93,94

No statistically significant 

difference was reported by 

any of the three studies.

Low -1 0 0 0 0 0 0 0 Very Low

Recipient Low

survival

Three 

observational 

studies 

16,77,79,83,84

Two of the three studies 

reported results in favor of 

receiving an organ from a 

negative donor. The third 

study found a statistically 

nonsignificant result.

Low -1 0 0 0 0 +1 0 0 Low
419

Comparison Outcome

Quantity and 

Type of 

Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE of 

Evidence 

for 

Outcome

Overall

GRADE of

Evidence

Stu

Base

dy Quality

Consistency

Directness

Precision

Publication BiasLarge MagnitudeDose ResponseConfounders would reduce the effect

Receiving an HBV+ organ 

compared to receiving a 

negative organ for 

recipients who were 

POSITIVE before 

transplant

Graft 

survival

Four 

observational 

studies55,56,91,9

5-97

Only one of the four studies 

reported any statistically 

significant difference. This 

study found that if the 

kidney donor was living, 

results slightly favored 

receiving an organ from an 

HBsAg+ donor, whereas if 

the kidney donor was 

deceased, results favored 

receiving an organ from an 

HBsAg- donor.

Low -1 -1 0 0 0 0 0 0 Very Low

Very Low

Recipient 

survival

Three 

observational 

studies55,91,95-

97

Only one of the three 

studies reported any 

statistically significant 

difference. This study found 

that if the kidney donor was 

living, there was no 

statistically significant 

difference, whereas if the 

kidney donor was 

deceased, results favored 

receiving an organ from an 

HBsAg- donor.

Low -1 -1 0 0 0 0 0 0 Very Low
420

Comparison Outcome

Quantity and 

Type of 

Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE of 

Evidence 

for 

Outcome

Overall

GRADE of

Evidence

Stu

Base

dy Quality

Consistency

Directness

Precision

Publication BiasLarge MagnitudeDose ResponseConfounders would reduce the effect

Receiving a HCV+ organ 

compared to receiving a 

negative organ for 

recipients who were 

POSITIVE before 

transplant

Graft 

survival

13 

observational 

studies12,16,83-

94,98,99

No statistically significant 

difference was reported by 

any of the 13 studies.

Low -1 0 0 0 0 0 0 0 Very Low

Very Low

Recipient 

survival

11 

observational 

studies12,16,83-

92,98

Only 2 of the 11 studies 

found any statistically 

significant difference. 

One of the two favored 

recipients of organs of 

positive donors, and the 

other favored recipients of 

organs of negative donors.

Low -1 0 0 0 0 0 0 0 Very Low

Note: The shaded rows denote recipient survival, which was considered a “critical” outcome. Graft survival is unshaded because it was not considered “critical” for the purpose of evidence grading.
421

Additional Evidence Tables for Question 7

Table 64. Question 7: General Information about Included Studies

Study Country Center(s) or Program(s) Organ

Number of 

Centers

Transplantation 

Dates Funding

Recipients Negative Before Transplant; Comparison of Clinical Outcomes After HBV+ Donor vs. HBV- Donor

Fong et al. (2002)55 USA UNOS Scientific Renal Transplant 

Registry

Kidney UNOS 1994 to 1999 NR

Recipients Negative Before Transplant; Comparison of Clinical Outcomes After HCV+ Donor vs. HCV- Donor

Abbott et al. (2003)83,84 USA United States Renal Data System 

(USRDS)

Kidney USRDS Jan-96 to May-01 NR

Velidedeoglu et al. (2002)93,94 USA University of Pennsylvania (Penn), 

Philadelphia, PA, and UNOS

Liver 1 Jan-95 to Dec-99 NR

Shah et al. (1993)12,16 USA University of Pittsburgh 

School of Medicine, Pittsburgh, PA

Liver 1 Mar-86 to Mar-90 NR

Haji et al. (2004)77,79 USA Cleveland Clinic, Cleveland, OH Heart 1 Jul-93 to Dec-98 NR

Recipients Positive Before Transplant; Comparison of Clinical Outcomes After HBV+ Donor vs. HBV- Donor

Fong et al. (2002)55 USA UNOS Scientific Renal Transplant 

Registry

Kidney UNOS 1994 to 1999 NR

Madayag et al. (1997)56 USA University of Maryland, Baltimore, MD Kidney 1 Jan-92 to Jul-96 NR

Lai et al. (1996)95-97 Taiwan National Taiwan University, 

Taipei, Taiwan

Kidney NR Jul-81 to Jan-94 NR

Saab et al. (2003)91 USA Dumont-UCLA Liver Transplant 

Center, Los Angeles, CA

Liver 1 Jan-90 to Apr-01 NR
422

Study Country Center(s) or Program(s) Organ

Number of 

Centers

Transplantation 

Dates Funding

Recipients Positive Before Transplant; Comparison of Clinical Outcomes After HCV+ Donor vs. HCV- Donor

Kasprzyk et al. (2007)98 Poland Medical University of Wroclas, 

Wroclas, Poland

Kidney NR Jul-94 to Jul-06 NR

Abbott et al. (2003)83,84 USA USRDS Kidney USRDS Jan-96 to May-01 NR

Woodside et al. (2003)85 USA University of Texas Medical Branch, 

Galveston, TX

Kidney 1 Jul-92 to Jul-00 NR

Mandal et al. (2000)86 USA Johns Hopkins Hospital, 

Baltimore, MD

Kidney 1 Jan-97 to Jun-99 NR

Ali et al. (1998)99 USA Washington Hospital Center, 

Washington, DC

Kidney 1 Feb-91 to Sep-96 NR

Morales et al. (1995)87 Spain Hospital 12 de Octubre, Madrid, and 

Hospital Clinic, Barcelona

Kidney 2 Mar-90 to Dec-92 Partially 

supported by FIS 

grant No. 94/1002

Saab et al. (2003)91 USA Dumont-UCLA Liver Transplant 

Center, Los Angeles, CA

Liver 1 Jan-90 to Apr-01 NR

Velidedeoglu et al. (2002)93,94 USA University of Pennsylvania, 

Philadelphia, PA, and UNOS

Liver 1 for Penn 

data, many 

for UNOS 

data

Jan-95 to Dec-99 NR

Marroquin et al. (2001)90 USA UNOS Scientific Renal Transplant 

Registry

Liver UNOS Apr-94 to Jun-97 NR

Salizzoni et al. (2001)88 Italy S. Giovanni Battista Hospital, Torino, 

Italy

Liver 1 Jul-98 to Dec-99 NR

Vargas et al. (1999)92 USA Thomas E. Starzl Transplantation 

Institute, Pittsburgh, PA

Liver 1 Feb-92 to May-05 NR

Testa et al. (1998)89 USA Baylor University Medical Center, 

Dallas, Texas

Liver 1 Jul-85 to Jul-95 NR
423

Study Country Center(s) or Program(s) Organ

Number of 

Centers

Transplantation 

Dates Funding

Shah et al. (1993)12,16 USA University of Pittsburgh 

School of Medicine, Pittsburgh, PA

Liver 1 Mar-86 to Mar-90 NR

NR – Not reported
424

Table 65. Question 7: Details of Study Methods

Study

ProspectiveConsecutive

Duration of Follow-up

N Enrolled for D+N Enrolled for DDefinition of 

Positivity

Specific Test 

Used

Recipients Negative Before Transplant; Comparison of Clinical Outcomes after HBV+ Donor vs. HBV- Donor

Fong et al. (2002)55 No Yes NR 763 24,661 anti-HBc+ NR

Recipients Negative Before Transplant; Comparison of Clinical Outcomes after HCV+ Donor vs. HCV- Donor

Abbott et al. (2003)83,84 No Yes Mean: 33 (SD: 20) 280 34,151 anti-HCV “Presumably 

ELISA”

Velidedeoglu et al. (2002)93,94 No Yes For Pennsylvania data, the 

mean followup was 23.4 months.

For UNOS data, the 

mean followup was 22.4 months.

29 7,811 “HCV+” NR

Shah et al. (1993)12,16 No No NR 25 375 anti-HCV ELISA2

Haji et al. (2004)77,79 No No Mean: 50 months (SD: 23) 34 183 anti-HCV ELISA2

Recipients Positive Before Transplant; Comparison of Clinical Outcomes after HBV+ Donor vs. HBV- Donor

Fong et al. (2002)55 No Yes NR 140 2,093 anti-HBc+ NR

Madayag et al. (1997)56 No Yes Mean: 24 (Range: 2-64) 45 45 Donor anti-HBc+ and 

HBsAg-; Recipient had 

prior HBV infection or 

had been vaccinated

Abbott tests

Lai et al. (1996)95-97 No Yes NR 25 42 HBsAg Austria II and 

Ausab (Abbott)
425

Study

ProspectiveConsecutive

Duration of Follow-up

N Enrolled for D+N Enrolled for DDefinition of 

Positivity

Specific Test 

Used

Saab et al. (2003)91 No NR For HBV+ recipients, 

mean follow-up for patient 

survival data was 2.3 years 

(Range: 0-8.7), and for graft 

survival data was 2.0 years 

(Range: 0-8.7).

For HCV+ recipients, 

mean follow-up for patient

survival data was 2.6 years 

(Range: 0-5.8), and for graft 

survival data was 1.8 years 

(Range: 0-5.8).

74 42 anti-HBc+ NR

Recipients Positive Before Transplant; Comparison of Clinical Outcomes after HCV+ Donor vs. HCV- Donor

Kasprzyk et al. (2007)98 No Yes Range: 12-156 60 199 anti-HCV NR

Abbott et al. (2003)83,84 No Yes Mean: 33 (SD: 20) 593 1,932 anti-HCV “Presumably 

ELISA”

Woodside et al. (2003)85 No Yes Mean: 26 months 

(Range: 0.4-119) for those who 

received a positive organ, and 

34 months (Range: 0.2-66) for 

those who received a negative 

organ

20 20 “seropositive” NR

Mandal et al. (2000)86 No Yes Median: 16, 

Mean: 15 (standard error of the 

mean: 2), 

Range: 3-33

18 10 anti-HCV and 

HCV-RNA+

HCV RNA 

measured by PCR

Ali et al. (1998)99 No Yes Mean: 36, 

Range: 12-60

28 16 anti-HCV NR
426

Study

ProspectiveConsecutive

Duration of Follow-up

N Enrolled for D+N Enrolled for DDefinition of 

Positivity

Specific Test 

Used

Morales et al. (1995)87 NR Yes Mean: 26 months (SD: 8) for 

those who received a positive 

organ, and 30 months (SD: 10) 

for those who received a 

negative organ

24 40 anti-HCV ELISA2 (Ortho) 

and RIBA (Chiron)

Saab et al. (2003)91 No NR For HBV+ recipients, 

mean follow-up for 

patient survival data was 

2.3 years (Range: 0-8.7), and 

for graft survival data was 

2.0 years (Range: 0-8.7).

For HCV+ recipients, 

mean follow-up for 

patient survival data was 

2.6 years (Range: 0-5.8), and 

for graft survival data was 

1.8 years (Range: 0-5.8)

27 212 anti-HCV NR

Velidedeoglu et al. (2002)93,94 No Yes For Penn data, the 

mean followup was 23.4 months.

For UNOS data, the 

mean followup was 22.4 months.

Penn:

13;

UNOS:

190

Penn:

103;

UNOS:

5,053

Penn: “HCV+”; 

UNOS: Donors were 

anti-HCV+, and of 

recipients, 96% were 

anti-HCV+ and 

4% were RIBA+ and/or 

HCV-RNA+

NR

Marroquin et al. (2001)90 No Yes Median was 34 months for those 

who received a positive organ, 

and 37 months for those who 

received a negative organ

96 2,827 “HCV+” NR
427

Study

ProspectiveConsecutive

Duration of Follow-up

N Enrolled for D+N Enrolled for DDefinition of 

Positivity

Specific Test 

Used

Salizzoni et al. (2001)88 No NR Mean: 12, 

Range: 1-25

12 103 anti-HCV NR

Vargas et al. (1999)92 No Yes NR 23 169 anti-HCV ELISA3 (Abbott)

Testa et al. (1998)89 No Yes Mean:

40 months (Range: 12-58) for 

those who received a 

positive organ, and 

36 months (Range: 17-135) for 

those who received a 

negative organ

22 115 anti-HCV ELISA1 until 1990, 

then ELISA2

Shah et al. (1993)12,16 No No NR 5 111 anti-HCV ELISA2

NR – Not reported
428

Table 66. Question 7: Pre-transplant Patient Characteristics

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Recipients Negative Before Transplant; Comparison of Clinical Outcomes After HBV+ Donor vs. HBV- Donor

Fong et al. (2002)55 Donor % African-American 17%

(130/763)

10%

(2,466/24,661)

7 p.p.

Donor % death due to stroke 51%

(389/763)

36%

(8,878/24,661)

15 p.p. Large difference 

at baseline.

Donor % HCV+ 11%

(84/763)

2%

(493/24,661)

9 p.p.

Donor % male 42%

(320/763)

41%

(10,111/24,661)

1 p.p.

Recipient % African-American 34%

(259/763)

25%

(6,165/24,661)

9 p.p.

Recipient % Asian-American 5%

(38/763)

3%

(740/24,661)

2 p.p.

Recipient % HCV+ 11%

(84/763)

5%

(1,233/24,661)

6 p.p.

Recipient % male 63%

(481/763)

61%

(15,043/24,661)

2 p.p.

Recipient % being retransplanted 12%

(92/763)

13%

(3,206/24,661)

1 p.p.

Mean Cold ischemia time (hours) 22.1

(SD: 8.5)

20.6

(SD: 8.2)

g = 0.18

Mean Donor age 40.5

(SD: 16)

33.7

(SD: 18.1)

g = 0.38
429

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Number of HLA mismatches 3.7

(SD: 1.6)

3.4

(SD: 1.8)

g = 0.17

Mean Recipient age 47.8

(SD: 13.1)

45.5

(SD: 14.2)

g = 0.16

Recipient duration of dialysis (months) 38.1

(SD: 34.6)

36.6

(SD: 36.9)

g = 0.04

Recipient Peak Panel Reactive Antibody 13.2

(SD: 24.3)

14

(SD: 25.8)

g = 0.03

Recipients Negative Before Transplant; Comparison of Clinical Outcomes After HCV+ Donor vs. HCV- Donor

Abbott et al. (2003)83,84, 

Velidedeoglu et al. (2002)93,94

These studies did not report pre-transplant characteristics comparing those who received organs from infected donors vs. 

those who received organs from uninfected donors

Shah et al. (1993)12,16 Study only reported that “No statistical difference in disease indication for OLTx was evident between the 4 study groups”

Haji et al. (2004)77,79 % “Cause” was dilated cardiomyopathy 32%

(11/34)

34%

(62/183)

2 p.p.

% “Cause” was ischemic cardiomyopathy 62%

(21/34)

56%

(102/183)

6 p.p.

% “Cause” was something else 5%

(2/34)

9%

(16/183)

4 p.p.

Donor % male 74%

(25/34)

57%

(104/183)

17 p.p. Large difference 

at baseline.

Recipient % male 76%

(26/34)

79%

(145/183)

3 p.p.

Mean Donor age 39

(SD: 9)

35

(SD: 14)

g = 0.3
430

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Mean Recipient age 57

(SD: 10)

52

(SD: 11)

g = 0.46 Large difference 

at baseline.

Mean Recipient average biopsy score 1.31

(SD: 0.65)

1.51

(SD: 0.66)

g = 0.3

Mean number of recipient episodes of acute 

rejection before this transplant

1.7

(SD: 1.5)

1.8

(SD: 1.6)

g = 0.06

Recipients Positive Before Transplant; Comparison of Clinical Outcomes After HBV+ Donor vs. HBV- Donor

Lai et al. (1996)95-97, 

Saab et al. (2003)91

These studies did not report pre-transplant characteristics comparing those who received organs from infected donors vs. 

those who received organs from uninfected donors

Fong et al. (2002)55 Donor % African-American 26%

(36/140)

13%

(272/2,093)

13 p.p.

Donor % death due to stroke 47%

(66/140)

37%

(774/2,093)

10 p.p.

Donor % HCV+ 22%

(31/140)

5%

(105/2,093)

17 p.p. Large difference 

at baseline.

Donor % male 34%

(48/140)

42%

(879/2,093)

8 p.p.

Recipient % African-American 56%

(78/140)

39%

(816/2,093)

17 p.p. Large difference 

at baseline.

Recipient % Asian-American 16%

(22/140)

10%

(209/2,093)

6 p.p.

Recipient % being retransplanted 8%

(11/140)

10%

(290/2,093)

2 p.p.

Recipient % HCV+ 35%

(49/140)

21%

(440/2,093)

14 p.p.
431

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Recipient % male 73%

(102/140)

64%

(1,340/2,093)

9 p.p.

Mean Cold ischemia time (hours) 20.6

(SD: 8.2)

20.7

(SD: 8.7)

g = 0.01

Mean Donor age 42.7

(SD: 13.9)

34.9

(SD: 18.2)

g = 0.43 Large difference 

at baseline.

Mean number of HLA mismatches 4.3

(SD: 1.4)

3.7

(SD: 1.7)

g = 0.36

Mean Recipient age 49.7

(SD: 10.7)

46.5

(SD: 14)

g = 0.23

Mean Recipient duration of dialysis (months) 42.1

(SD: 31.3)

44.2

(SD: 40.2)

g = 0.05

Mean Recipient Peak Panel Reactive 

Antibody

14.3

(SD: 23.6)

14.3

(SD: 25.6)

g = 0

Madayag et al. (1997)56 Donor % deceased 69%

(31/45)

58%

(26/45)

11 p.p.

Donor % living related 29%

(13/45)

40%

(18/45)

11 p.p.

Recipient % anti-lymphocyte therapy 40%

(18/45)

33%

(15/45)

7 p.p.

Recipient % Asian-American 60%

(27/45)

49%

(22/45)

11 p.p.

Recipient % Caucasian-American 26%

(12/45)

49%

(22/45)

23 p.p. Large difference 

at baseline.

Recipient % other race 13%

(6/45)

2%

(1/45)

11 p.p.
432

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Recipient % HCV+ 31%

(14/45)

31%

(14/45)

0 p.p.

Recipient % high-risk behavior 13%

(6/45)

18%

(8/45)

5 p.p.

Recipient % history of alcohol abuse 13%

(6/45)

7%

(3/45)

6 p.p.

Recipient % intraoperative or postoperative 

transfusion

85%

(38/45)

81%

(36/45)

4 p.p.

Recipient % male 68%

(31/45)

62%

(28/45)

6 p.p.

Recipient % Simultaneous kidney-pancreas 

transplant

2%

(1/45)

2%

(1/45)

0 p.p.

Recipient % with pre-transplant transfusion 60%

(27/45)

47%

(21/45)

13 p.p.

Mean Recipient age 49.1

(SD: 11.8)

43.6

(SD: 11.8)

g = 0.47 Large difference 

at baseline. 

Dispersion reported 

as “+/-” but authors 

did not specify what 

this was; ECRI 

Institute estimated 

the SD for each 

group to be 11.8 

based on the 

reported p = 0.03 for 

ANOVA

Recipient date of transplant The study intentionally matched 

patients on this characteristic
433

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Recipient Pre-transplant HBV serology The study intentionally matched 

patients on this characteristic

Type of organ transplanted The study intentionally matched 

patients on this characteristic

Recipients Positive Before Transplant; Comparison of Clinical Outcomes After HCV+ Donor vs. HCV- Donor

Kasprzyk et al. (2007)98, 

Abbott et al. (2003)83,84, 

Ali et al. (1998)99, 

Saab et al. (2003)91

These studies did not report pre-transplant characteristics comparing those who received organs from infected donors vs. 

those who received organs from uninfected donors

Woodside et al. (2003)85 % Immunosuppressive induction therapy 90%

(18/20)

80%

(16/20)

10 p.p.

CMV % donor/recipient pairs with both CMV- 5%

(1/20)

5%

(1/20)

0 p.p.

CMV % donor/recipient pairs with both CMV+ 70%

(14/20)

55%

(11/20)

15 p.p. Large difference 

at baseline.

CMV % donor/recipient pairs with only 

donor+

0%

(0/20)

10%

(2/20)

10 p.p.

CMV % donor/recipient pairs with only 

recipient+

20%

(4/20)

20%

(4/20)

0 p.p.

CMV % donor/recipient pairs with unknown 

recipient status

5%

(1/20)

0%

(0/20)

5 p.p.

Donor % anti-HBc+ 20%

(4/20)

20%

(4/20)

0 p.p.

Donor % HBsAg+ 0%

(0/20)

0%

(0/20)

0 p.p.
434

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Recipient % anti-HBc+ 20%

(4/20)

35%

(7/20)

15 p.p. Large difference 

at baseline.

Recipient % African-American 50%

(10/20)

45%

(9/20)

5 p.p.

Recipient % Asian-American 0%

(0/20)

10%

(2/20)

10 p.p.

Recipient % Caucasian-American 15%

(3/20)

35%

(7/20)

20 p.p. Large difference 

at baseline.

Recipient % Hispanic-American 35%

(7/20)

5%

(1/20)

30 p.p. Large difference 

at baseline.

Recipient % HBsAg+ 0%

(0/20)

0%

(0/20)

0 p.p.

Recipient % male 80%

(16/20)

65%

(13/20)

15 p.p. Large difference 

at baseline.

Recipient % being retransplanted 15%

(3/20)

15%

(3/20)

0 p.p.

Recipient % with 1 prior transplant 5%

(1/20)

10%

(2/20)

5 p.p.

Recipient % with 2 prior transplants 5%

(1/20)

5%

(1/20)

0 p.p.

Recipient % with 3 prior transplants 5%

(1/20)

0%

(0/20)

5 p.p.

Recipient Triple drug therapy % 100%

(20/20)

80%

(16/20)

20 p.p. Large difference 

at baseline.
435

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Mean Cold ischemia time (hours) 24.3

(SD: 9.8)

21.5

(SD: 2.7)

g = 0.39 ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns

Mean Recipient age 44

(SD: 13.4)

45

(SD: 44.7)

g = 0.03 ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns

Mean Recipient time on waitlist (months) 9.9

(SD: 8)

17.7

(SD: 14.8)

g = 0.66 Large difference 

at baseline. 

ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns

Mandal et al. (2000)86 Donor % CMV+ 87%

(16/18)

50%

(5/10)

37 p.p. Large difference 

at baseline.

Donor % history of alcohol abuse 5%

(1/18)

10%

(1/10)

5 p.p.

Donor % prior cocaine snorting or selling of 

drugs

NR NR NC

Recipient % African-American 66%

(12/18)

60%

(6/10)

6 p.p.

Recipient % CMV+ 83%

(15/18)

70%

(7/10)

13 p.p.

Recipient % male 66%

(12/18)

80%

(8/10)

14 p.p.

Recipient % with diabetes 28%

(5/18)

10%

(1/10)

18 p.p. Large difference 

at baseline.
436

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Recipient % with hypertension 33%

(6/18)

40%

(4/10)

7 p.p.

Recipient % being retransplanted 28%

(5/18)

60%

(6/10)

32 p.p. Large difference 

at baseline.

Mean AB mismatch 3.2

(SD: 0.8)

2.3

(SD: 0.9)

g = 1.08 Large difference 

at baseline. 

ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns

Mean Cold ischemia time (hours) 28

(SD: 8.5)

22

(SD: 9.5)

g = 0.68 Large difference 

at baseline. 

ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns

Mean Donor age 46

(SD: 8.5)

35

(SD: 19)

g = 0.84 Large difference 

at baseline. 

ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns

Mean DR mismatch 1.6

(SD: 0.8)

1.3

(SD: 0.3)

g = 0.45 Large difference 

at baseline. 

ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns
437

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Mean Recipient age 48

(SD: 8.5)

44

(SD: 6.3)

g = 0.51 Large difference 

at baseline. 

ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns

Mean Recipient duration of dialysis (months) 88

(SD: 152.7)

79

(SD: 66.4)

g = 0.07 ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns

Mean Recipient Terminal creatinine (mg/dL) 0.9

(SD: 0.8)

0.9

(SD: 0.6)

g = 0 ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns. One 

of the reported SDs 

was 0, which is not 

reasonable, 

therefore we used 

the SD from the 

other group

Mean Recipient time on waitlist (months) 9

(SD: 12.7)

29

(SD: 9.5)

g = 1.71 Large difference 

at baseline. 

ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns

Morales et al. (1995)87 Recipient % abnormal liver histology 31%

(7/24)

50%

(20/40)

19 p.p. Large difference 

at baseline.

Recipient % anti-HBc+ 50%

(12/24)

23%

(9/40)

27 p.p. Large difference 

at baseline.
438

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Recipient % chronic active hepatitis 0%

(0/24)

10%

(4/40)

10 p.p.

Recipient % chronic liver disease 4%

(1/24)

5%

(2/40)

1 p.p.

Recipient % chronic persistent hepatitis 17%

(4/24)

8%

(3/40)

9 p.p.

Recipient % elevated ALT 54%

(13/24)

50%

(20/40)

4 p.p.

Recipient % HBsAg+ 8%

(2/24)

3%

(1/40)

5 p.p.

Recipient % hemosiderosis 0%

(0/24)

5%

(2/40)

5 p.p.

Recipient % history of drug abuse 0%

(0/24)

0%

(0/40)

0 p.p.

Recipient % HIV+ 0%

(0/24)

0%

(0/40)

0 p.p.

Recipient % male 67%

(16/24)

60%

(24/40)

7 p.p.

Recipient % mild elevated ALT 50%

(12/24)

45%

(18/40)

5 p.p.

Recipient % PCR+ 71%

(17/24)

79%

(32/40)

8 p.p.

Recipient % renal disease: 

arterial hypertension

8%

(2/24)

7%

(3/40)

1 p.p.

Recipient % renal disease: 

chronic glomerulonephritis

55%

(13/24)

35%

(14/40)

20 p.p. Large difference 

at baseline.
439

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Recipient % renal disease: 

chronic interstitial nephritis

29%

(7/24)

33%

(13/40)

4 p.p.

Recipient % renal disease: cystic disease 0%

(0/24)

5%

(2/40)

5 p.p.

Recipient % renal disease: other 8%

(2/24)

20%

(8/40)

12 p.p.

Recipient % RIBA+ 100%

(24/24)

100%

(40/40)

0 p.p.

Recipient % being retransplanted 8%

(2/24)

20%

(8/40)

12 p.p.

Mean Recipient age 47

(SD: 12)

44

(SD: 14)

g = 0.23

Mean Recipient duration of dialysis (months) 72

(SD: 53)

75

(SD: 49)

g = 0.06

Mean Recipient pre-transplant number of 

transfusions

7

(SD: 8)

21

(SD: 39)

g = 0.45 Large difference 

at baseline.

Velidedeoglu et al. (2002)93,94 Recipient % UNOS status 1 23.1%

(3/13)

15.4%

(16/103)

7.7 p.p. Only reported 

comparative 

characteristics for 

the Penn data, not 

for the UNOS data

Recipient % UNOS status 2A 15.4%

(2/13)

24.2%

(25/103)

8.8 p.p. Only reported 

comparative 

characteristics for 

the Penn data, not 

for the UNOS data
440

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Recipient % UNOS status 2B 61.5%

(8/13)

60.4%

(62/103)

1.1 p.p.

Mean Cold ischemia time (hours) 8.5

(SD: 3.2)

8.5

(SD: 3)

g = 0 ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns. 

Only reported 

comparative 

characteristics for 

the Penn data, not 

for the UNOS data

Mean Donor age 36.5

(SD: 8.7)

36.9

(SD: 16.2)

g = 0.03 ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns. 

Only reported 

comparative 

characteristics for 

the Penn data, not 

for the UNOS data

Mean Recipient age 52.6

(SD: 8.3)

50.2

(SD: 8.1)

g = 0.3 ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns. 

Only reported 

comparative 

characteristics for 

the Penn data, not 

for the UNOS data
441

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Mean Warm ischemia time (hours) 51

(SD: 15.1)

50.6

(SD: 42.6)

g = 0.01 ECRI Institute 

estimated the SDs 

using the reported 

SEMs and Ns. One 

of the reported SDs 

was 0, which is not 

reasonable, 

therefore we used 

the SD from the 

other group. Only 

reported 

comparative 

characteristics for 

the Penn data, not 

for the UNOS data

Marroquin et al. (2001)90 ABO % incompatibility 4.2%

(4/96)

1.3%

(37/2,827)

2.9 p.p.

Donor % cause of death: cardiovascular 

event

1%

(1/96)

3.2%

(90/2,827)

2.2 p.p.

Donor % cause of death: cerebrovascular 

accident

46.9%

(45/96)

39.8%

(1,125/2,827)

7.1 p.p.

Donor % cause of death: head trauma 45.8%

(44/96)

50.6%

(1,430/2,827)

4.8 p.p.

Donor % cause of death: other 6.3%

(6/96)

6.4%

(181/2,827)

0.1 p.p.

Donor % male 68.8%

(66/96)

63.3%

(1,789/2,827)

5.5 p.p.

Recipient % hepatocellular carcinoma 8.3%

(8/96)

3.1%

(88/2,827)

5.2 p.p.
442

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Recipient % male 67.6%

(65/96)

68.5%

(1,936/2,827)

0.9 p.p.

Recipient % use of vasopressor 68.7%

(66/96)

67%

(1,894/2,827)

1.7 p.p.

Recipient % being retransplanted 4%

(4/96)

10%

(277/2,827)

6 p.p.

Recipient % year of transplant 1997 (the last 

year of study enrollment)

21%

(20/96)

15%

(424/2,827)

6 p.p.

Mean Cold ischemia time (hours) 9.4

(SD: NR)

8.8

(SD: NR)

g = 0.07 Dispersion not 

reported, but 

p >0.05 reported. 

ECRI Institute 

estimated 

Hedges’ g using an 

estimated SD of 8.2 

for both groups, 

which was based on 

pooling on other 

studies’ reported 

SDs for this 

characteristic.
443

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or% for 

Recipients of D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Mean Donor age 38.5

(SD: NR)

35.8

(SD: NR)

g= 0.15 Dispersion not 

reported, but p >0.05 reported. 

ECRI Institute 

estimated 

Hedges’ g using an 

estimated SD of 18 

for both groups, 

which was based on 

pooling on other 

studies’ reported 

SDs for this 

characteristic.

Mean Recipient age 49.5

(SD: NR)

48.6

(SD: NR)

g= 0.06 Dispersion not 

reported, but p >0.05 reported. ECRI Institute 

estimated 

Hedges’ g using an 

estimated SD of 

14.1 for both 

groups, which was 

based on pooling on 

other studies’ 

reported SDs for 

this characteristic.

Mean Recipient creatinine mg/dL 1.2

(SD: NR)

1.2

(SD: NR)

NC Dispersion not 

reported, but p >0.05 reported

Mean Recipient hospital stay (days) 18.7 (SD: NR)

27.1

(SD: NR)

NC Dispersion not 

reported, but p >0.05 reported
444

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Mean Recipient ICU stay (days) 11.5

(SD: NR)

15.1

(SD: NR)

NC Dispersion not 

reported, but 

p >0.05 reported

Mean Recipient weight (kg) 73.6

(SD: NR)

72.9

(SD: NR)

NC Dispersion not 

reported, but 

p >0.05 reported

Mean Warm ischemia time (hours) 45.9

(SD: NR)

46.8

(SD: NR)

NC Dispersion not 

reported, but 

p >0.05 reported

Salizzoni et al. (2001)88 Mean Donor age 62.6

(SD: NR)

53.7

(SD: NR)

g = 0.49 Large difference 

at baseline. These 

are medians. 

Dispersion not 

reported, but 

authors stated there 

was “no significant 

difference”. 

ECRI Institute 

estimated 

Hedges’ g using an 

estimated SD of 18 

for both groups, 

which was based on 

pooling on other 

studies’ reported 

SDs for this 

characteristic.
445

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Mean Recipient coagulation time (INR) 1.2

(SD: NR)

1.2

(SD: NR)

NC These are medians. 

Dispersion not 

reported, but 

authors stated there 

was “no significant 

difference”

Mean Recipient hepatic enzymes ALT (U/L) 24

(SD: NR)

22

(SD: NR)

NC These are medians. 

Dispersion not 

reported, but 

authors stated there 

was “no significant 

difference”

Mean Recipient hepatic enzymes AST (U/L) 24

(SD: NR)

21

(SD: NR)

NC These are medians. 

Dispersion not 

reported, but 

authors stated there 

was “no significant 

difference”

Mean Recipient platelet concentration (109/L) 177

(SD: NR)

215

(SD: NR)

NC These are medians. 

Dispersion not 

reported, but 

authors stated there 

was “no significant 

difference”

Mean Total ischemia time (hours) 10.3

(SD: NR)

9.8

(SD: NR)

NC Dispersion not 

reported, but 

authors stated there 

was “no significant 

difference”
446

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Mean Warm ischemia time (hours) 0.6

(SD: NR)

0.53

(SD: NR)

NC These are medians. 

Dispersion not 

reported, but 

authors stated there 

was “no significant 

difference”

Vargas et al. (1999)92 Recipient % male 74%

(17/23)

85%

(144/169)

11 p.p.

Mean Recipient age 51.1

(SD: 10.4)

49.5

(SD: 11.7)

g = 0.14 SD of the age of 

recipients of 

infected organs was 

calculated by 

ECRI Institute 

based on Table 1 of 

the article. SD of the 

age of recipients of 

uninfected organs 

was calculated by 

ECRI Institute using 

the reported SEM of 

0.9 and the N for 

that group which 

was 169
447

Study Characteristic

Mean (SD) 

or % for 

Recipients 

of 

D+ Organs

Mean (SD) 

or % for 

Recipients of 

D- Organs

Difference in 

percentage 

points (p.p.), 

or Hedges’ g Comments

Testa et al. (1998)89 Recipient % male 50%

(11/22)

73%

(84/115)

23 p.p. Large difference 

at baseline.

Mean Recipient age 48.2

(SD: NR)

47.1

(SD: NR)

g = 0.08 Neither SD nor SEM 

were reported, and 

no statistical test 

reported. 

ECRI Institute 

estimated 

Hedges’ g using an 

estimated SD of 

14.1 for both 

groups, which was 

based on pooling on 

other studies’ 

reported SDs for 

this characteristic.

Shah et al. (1993)12,16 Study only reported that “No statistical difference in disease indication for OLTx was evident between the 4 study groups”

Note: Shaded cells denote comparisons for which the groups differed at baseline by 15 or more percentage points (dichotomous outcomes) or for which the groups 

differed at baseline by Hedges’ g of 0.4 or more (continuous measures). Hedges’ g is the difference between means divided by the pooled standard deviation.

This was calculated by ECRI Institute.

NC – Not calculable

NR – Not reported

p.p. – Percentage points

SD – Standard deviation

SEM – Standard error of the mean
448

Table 67. Question 7: Quality Assessment

Study 7a 7b 7c 7d 7e 7f 7g 7h

Recipients Negative Before Transplant; Comparison of Clinical Outcomes After HBV+ Donor vs. HBV- Donor

Fong et al. (2002)55  

Recipients Negative Before Transplant; Comparison of Clinical Outcomes After HCV+ Donor vs. HCV- Donor

Abbott et al. (2003)83,84     

Velidedeoglu et al. (2002)93,94  

Shah et al. (1993)12,16 

Haji et al. (2004)77,79   

Recipients Positive Before Transplant; Comparison of Clinical Outcomes After HBV+ Donor vs. HBV- Donor

Fong et al. (2002)55   

Madayag et al. (1997)56     

Lai et al. (1996)95-97  

Saab et al. (2003)91 

Recipients Positive Before Transplant; Comparison of Clinical Outcomes After HCV+ Donor vs. HCV- Donor

Kasprzyk et al. (2007)98    

Abbott et al. (2003)83,84     

Woodside et al. (2003)85    

Mandal et al. (2000)86    

Ali et al. (1998)99    

Morales et al. (1995)87    

Saab et al. (2003)91 

Velidedeoglu et al. (2002)93,94   

Marroquin et al. (2001)90      

Salizzoni et al. (2001)88 

Vargas et al. (1999)92     

Testa et al. (1998)89    

Shah et al. (1993)12,16 

A checkmark () means that the study met the quality criterion for this Question; the lack of a checkmark means that the study either did not

meet the criterion, or it was unclear whether the study met the criterion. The criteria specific to this Question were: 

7a. Were the patients randomly assigned to treatments?

7b. Was the study planned prospectively (i.e., before any data were collected)

7c. Were all consecutive patients enrolled (or a random sample of eligible patients)?

7d. Were the two groups comparable at baseline? (age, sex, comorbidities, indication for transplant, previous duration on waitlist)

7e. If not, were statistical adjustments performed to control for baseline differences? 

7f. Were the two groups treated concurrently?

7g. Did at least 85% of the study enrollees provide data?

7h. Was the between-group difference in study completion rates less than 15%?
449

Table 68. Question 7: Reported Data

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Recipients Negative Before Transplant; Comparison of Clinical Outcomes After HBV+ Donor vs. HBV- Donor

Fong et al. (2002)55 Graft 

survival

12 87%

(N = Not 

reported [NR])

88%

(N = NR)

None Overall graft 

survival curve:

p = 0.009 for 

D+R- vs. D-R-;

p = 0.06 for 

D-R+ vs. D-R-;

p = 0.69 for 

D+R+ vs. D-RSurvival 

percentages 

estimated by 

ECRI Institute 

from Figure 1 in the 

article

Graft 

survival

24 78%

(N = NR)

83%

(N = NR)

None Overall graft 

survival curve:

p = 0.009 for 

D+R- vs. D-R-;

p = 0.06 for 

D-R+ vs. D-R-;

p = 0.69 for 

D+R+ vs. D-RSurvival 

percentages 

estimated by 

ECRI Institute 

from Figure 1 in the 

article

Graft 

survival

36 72%

(N = NR)

77%

(N = NR)

None Overall graft 

survival curve:

p = 0.009 for 

D+R- vs. D-R-;

p = 0.06 for 

D-R+ vs. D-R-;

p = 0.69 for D+R+ 

vs. D-RSurvival 

percentages 

estimated by 

ECRI Institute 

from Figure 1 in the 

article

Patient 

survival

12 94%

(N = NR)

94%

(N = NR)

None Overall patient 

survival curve:

p = 0.01 for 

D+R- vs. D-RSurvival 

percentages 

estimated by 

ECRI Institute 

from Figure 2 in the 

article
450

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Patient 

survival

24 90%

(N = NR)

92%

(N = NR)

None Overall patient 

survival curve:

p = 0.01 for 

D+R- vs. D-RSurvival 

percentages 

estimated by 

ECRI Institute 

from Figure 2 in the 

article

Patient 

survival

36 86%

(N = NR)

90%

(N = NR)

None Overall patient 

survival curve:

p = 0.01 for 

D+R- vs. D-RSurvival 

percentages 

estimated by 

ECRI Institute 

from Figure 2 in the 

article

Recipients Negative Before Transplant; Comparison of Clinical Outcomes After HCV+ Donor vs. HCV- Donor

Abbott et al. (2003)83,84 Graft 

survival

NA Relative risk was 0.97 (95% CI: 

0.6 to 1.56) (very slightly in 

favor of recipients of positive 

organs)

None n.s.

Patient 

survival, 

hazard 

ratio of 

death

NA Unadjusted hazard ratio of 

death was 2.30 (95% CI: 1.75 to 

3.26) in favor of recipients of 

negative organs.

None Significant

Patient 

survival, 

hazard 

ratio of 

death

NA Adjusted hazard ratio of death 

was 2.25 (95% CI: 1.56 to 3.24) 

in favor of recipients of negative 

organs.

Donor age, recipient 

age, HLA mismatch, 

elevated creatinine 

at 1 year posttransplantation, 

years of dialysis before 

transplantation, and 

albumin level.

Significant
451

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Velidedeoglu et al. 

(2002)93,94

UNOS data

Graft 

survival

12 80.9%

(N = 29)

82.3%

(N = 7,811)

None NR

Graft 

survival

36 69.2%

(N = NR)

76%

(N = NR)

None NR

Graft 

survival

60 69.2%

(N = NR)

70.1%

(N = NR)

None NR

Shah et al. (1993)12,16 Graft 

survival

24 60%

(N = NR)

69%

(N = NR)

None n.s.

Patient 

survival

24 60%

(N = NR)

75%

(N = NR)

None n.s.
452

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Haji et al. (2004)77,79 Patient 

survival

12 80%

(N = NR)

96%

(N = NR)

Not reported. The 

methods section 

reported the use of 

Cox regression 

“to adjust for significant 

covariates”, but authors 

did not report whether 

the hazard ratio of 2.8 

was adjusted or 

unadjusted. They did 

report that “By univariate 

Cox regression, recipient 

and donor age, 

ischemia time, 

cumulative episodes of 

rejection, standard 

biopsy score, donor and 

recipient 

cytomegalovirus 

seropositivity, and 

post-transplant 

cytomegalovirus 

infection were not 

significant (All p-values 

>0.1) in determining 

mortality in our patient 

population.” (page 280)

Overall p-value

for the survival 

curves was 

reported as 

p = 0.004 in favor 

of D- recipients

Confounding by 

indication: “At our 

institution, an 

HCV-seropositive 

donor was used 

when, in the 

judgment of the 

transplant team, 

the recipient was 

critically ill and 

not a candidate for 

mechanical 

ventricular assist 

device (recurrent 

stroke, infections)” 

(page 278) 

However, one 

criterion for 

inclusion in the 

analysis was that 

all patients must 

have been 

discharged home 

successfully 

i.e., went home in 

stable condition. 

Survival 

percentages 

estimated by 

ECRI Institute 

from Figure 1 in the 

article
453

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Patient 

survival

36 78%

(N = NR)

92%

(N = NR)

Not reported. The 

methods section 

reported the use of 

Cox regression “to 

adjust for significant 

covariates”, but authors 

did not report whether 

the hazard ratio of 2.8 

was adjusted or 

unadjusted. They did 

report that “By univariate 

Cox regression, recipient 

and donor age, ischemia 

time, cumulative 

episodes of rejection, 

standard biopsy score, 

donor and recipient 

cytomegalovirus 

seropositivity, and 

post-transplant 

cytomegalovirus 

infection were not 

significant (All p-values 

>0.1) in determining 

mortality in our patient 

population.” (page 280)

Overall p-value

for the survival 

curves was 

reported as 

p = 0.004 in favor 

of D- recipients

Survival 

percentages 

estimated by 

ECRI Institute 

from Figure 1 in the 

article
454

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Patient 

survival

60 59%

(N = NR)

88%

(N = NR)

Not reported. The 

methods section 

reported the use of 

Cox regression “to 

adjust for significant 

covariates”, but authors 

did not report whether 

the hazard ratio of 2.8 

was adjusted or 

unadjusted. They did 

report that “By univariate 

Cox regression, recipient 

and donor age, 

ischemia time, 

cumulative episodes of 

rejection, standard 

biopsy score, donor and 

recipient 

cytomegalovirus 

seropositivity, and 

post-transplant 

cytomegalovirus 

infection were not 

significant (All p-values 

>0.1) in determining 

mortality in our patient 

population.”(page 280)

Overall p-value

for the survival 

curves was 

reported as 

p = 0.004 in favor 

of D- recipients

Survival 

percentages 

estimated by 

ECRI Institute 

from Figure 1 in the 

article

Patient 

survival, 

rate

Mean: 

50 months 

(SD: 23)

68%

(23/34)

85%

(155/183)

None Relative risk or 

mortality:

2.8

(95% CI: 1.3-5.7; 

p = 0.006) in favor 

of D- recipients
455

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Recipients Positive Before Transplant; Comparison of Clinical Outcomes After HBV+ Donor vs. HBV- Donor

Fong et al. (2002)55 Graft 

survival

12 91%

(N = NR)

86%

(N = NR)

Adjusted for previous 

transplant, recipient age, 

recipient race, peak 

panel reactive antibody, 

recipient HCV, duration 

of dialysis, donor age, 

cold ischemia time, 

donor race, cause of 

donor death, ABDRMM 

(definition of this 

acronym not provided)

NR Percentage 

estimated by 

ECRI Institute 

from Figure 1 in the 

publication

Graft 

survival

24 80%

(N = NR)

83%

(N = NR)

Adjusted for previous 

transplant, recipient age, 

recipient race, peak 

panel reactive antibody, 

recipient HCV, duration 

of dialysis, donor age, 

cold ischemia time, 

donor race, cause of 

donor death, ABDRMM 

(definition of this 

acronym not provided)

NR Percentage 

estimated by 

ECRI Institute 

from Figure 1 in the 

publication

Graft 

survival

36 68%

(N = NR)

75%

(N = NR)

Adjusted for previous 

transplant, recipient age, 

recipient race, peak 

panel reactive antibody, 

recipient HCV, duration 

of dialysis, donor age, 

cold ischemia time, 

donor race, cause of 

donor death, ABDRMM 

(definition of this 

acronym not provided)

NR Percentage 

estimated by 

ECRI Institute 

from Figure 1 in the 

publication
456

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Patient 

survival

12 95%

(N = NR)

94%

(N = NR)

Adjusted for previous 

transplant, recipient age, 

recipient race, peak 

panel reactive antibody, 

recipient HCV, duration 

of dialysis, donor age, 

cold ischemia time, 

donor race, cause of 

donor death, ABDRMM 

(definition of this 

acronym not provided)

NR Percentage 

estimated by 

ECRI Institute 

from Figure 1 in the 

publication

Patient 

survival

24 94%

(N = NR)

91%

(N = NR)

Adjusted for previous 

transplant, recipient age, 

recipient race, peak 

panel reactive antibody, 

recipient HCV, duration 

of dialysis, donor age, 

cold ischemia time, 

donor race, cause of 

donor death, ABDRMM 

(definition of this 

acronym not provided)

NR Percentage 

estimated by 

ECRI Institute 

from Figure 1 in the 

publication

Patient 

survival

36 90%

(N = NR)

88%

(N = NR)

Adjusted for previous 

transplant, recipient age, 

recipient race, peak 

panel reactive antibody, 

recipient HCV, duration 

of dialysis, donor age, 

cold ischemia time, 

donor race, cause of 

donor death, ABDRMM 

(definition of this 

acronym not provided)

NR Percentage 

estimated by 

ECRI Institute 

from Figure 1 in the 

publication
457

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Madayag et al. (1997)56 Graft 

survival

12 93.4%

(N = 32)

100%

(N = 37)

Adjusted for sex, pretransplant HBsAg, 

pre-transplant anti-HBs, 

pre-transplant anti-HBc, 

organ type, and date of 

transplant

n.s. Recipients of 

positive organs 

were significantly 

older (Mean: 49 vs. 

44; p = 0.03).

Graft 

survival

36 86.1%

(N = 8)

100%

(N = 11)

Adjusted for sex, pretransplant HBsAg, 

pre-transplant anti-HBs, 

pre-transplant anti-HBc, 

organ type, and date of 

transplant

n.s. Recipients of 

positive organs 

were significantly 

older (Mean: 49 vs. 

44; p = 0.03).

Graft 

survival, 

cumulative 

graft loss 

risk

Mean: 24 

(Range:

2-64)

11%

(5/45)

2%

(1/45)

Adjusted for sex, 

pre-transplant HBsAg, 

pre-transplant anti-HBs, 

pre-transplant anti-HBc, 

organ type, and date of 

transplant

n.s.; Relative risk 

was 5.7 in favor 

(but not 

statistically 

significant) of the 

recipients of 

negative organs 

(95% CI: 0.52 to 

52.17

Recipients of 

positive organs 

were significantly 

older (Mean: 49 vs. 

44; p = 0.03).

Lai et al. (1996)95-97 Patient 

survival, 

living donor

12 100%

(N = NR)

91.7%

(N = NR)

None p = 0.334 for the 

comparison of

patient survival 

curves for 

D+ vs. D- when 

the donor was a 

living donor

Patient 

survival, 

deceased

donor

12 76.5%

(N = NR)

100%

(N = NR)

None p = 0.063 for the 

comparison of

patient survival 

curves for 

D+ vs. D- when 

the donor was 

deceased
458

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Patient 

survival, 

living donor

60 100%

(N = NR)

72.4%

(N = NR)

None p = 0.334 for the 

comparison of 

patient survival 

curves for 

D+ vs. D- when 

the donor was a 

living donor

Patient 

survival, 

deceased

donor

60 58.8%

(N = NR)

96.6%

(N = NR)

None p = 0.063 for the 

comparison of 

patient survival 

curves for 

D+ vs. D- when 

the donor was 

deceased

Graft 

survival, 

living donor

12 100%

(N = NR)

91.6%

(N = NR)

None p = 0.0013 for the 

comparison of 

graft survival 

curves for 

D+ vs. D- when 

the donor was a 

living donor

Graft 

survival, 

deceased

donor

12 76.5%

(N = NR)

100%

(N = NR)

None p = 0.0035 for the 

comparison of 

graft survival 

curves for 

D+ vs. D- when 

the donor was 

deceased

Graft 

survival, 

living donor

60 100%

(N = NR)

53.9%

(N = NR)

None p = 0.0013 for the 

comparison of 

graft survival 

curves for 

D+ vs. D- when 

the donor was a 

living donor
459

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Graft 

survival, 

deceased

donor

60 58.8%

(N = NR)

92.4%

(N = NR)

None p = 0.0035 for the 

comparison of 

graft survival 

curves for 

D+ vs. D- when 

the donor was 

deceased

Saab et al. (2003)91 Patient 

survival

12 94%

(N = NR)

91%

(N = NR)

None p = 0.65 

comparing the 

survival curves

Patient 

survival

36 73%

(N = NR)

81%

(N = NR)

None p = 0.65 

comparing the 

survival curves

Patient 

survival

60 73%

(N = NR)

81%

(N = NR)

None p = 0.65 

comparing the 

survival curves

Graft 

survival

12 87%

(N = NR)

84%

(N = NR)

None p = 0.94 

comparing the 

survival curves

Graft 

survival

36 71%

(N = NR)

75%

(N = NR)

None p = 0.94 

comparing the 

survival curves

Graft 

survival

60 71%

(N = NR)

75%

(N = NR)

None p = 0.94 

comparing the 

survival curves
460

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Recipients Positive Before Transplant; Comparison of Clinical Outcomes After HCV+ Donor vs. HCV- Donor

Kasprzyk et al. (2007)98 Graft 

survival

Range:

12-156

78%

(47/60)

70%

(140/199)

None n.s.; this statistical 

test result 

included 

recipients who 

were negative 

before transplant, 

but the 

percentages 

themselves in this 

table are 

restricted to those 

who were positive 

before transplant

Patient 

survival

Range:

12-156

95%

(57/60)

85%

(169/199)

None n.s.; this statistical 

test result 

included 

recipients who 

were negative 

before transplant, 

but the 

percentages 

themselves in this 

table are 

restricted to those 

who were positive 

before transplant
461

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Abbott et al. (2003)83,84 Patient 

survival

NR; see 

comments

Unadjusted hazard ratio of 

death was 1.43 (95% CI: 1.02 to 

2.02) in favor of recipients of 

negative organs.

None Significant This comparison 

was restricted to 

the ~90% of 

patients who 

survived at least 

2 years after 

transplant, 

because of the 

violation of the

proportional 

hazards 

assumption. There 

was no difference 

between groups up 

to 2 years posttransplant.

Patient 

survival

NR; see 

comments

Adjusted hazard ratio of death 

was 2.04 (95% CI: 1.20 to 3.45) 

in favor of recipients of negative 

organs.

Donor age,

recipient age, 

HLA mismatch, elevated 

creatinine at 1 year 

post-transplantation, 

years of dialysis before 

transplantation, and 

albumin level.

Significant This comparison 

was restricted to 

the ~90% of 

patients who 

survived at least 

2 years after 

transplant, 

because of the 

violation of the 

proportional 

hazards 

assumption. There 

was no difference 

between groups up 

to 2 years posttransplant.

Graft 

survival

NR 91.7%

(542/593)

90.9%

(769/846)

None NR Denominator for Dcalculated by 

ECRI Institute 

based on reported 

percentage and 

number of events
462

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Woodside et al. (2003)85 Graft 

survival

12 89%

(N = 19)

89%

(N = 19)

None NR

Patient 

survival

12 89%

(N = 17)

89%

(N = 17)

None NR

Mandal et al. (2000)86 Graft 

survival

Median: 16,

Mean: 15 

(standard 

error of the 

mean: 2),

Range:

3-33

56%

(11/19)

50%

(5/10)

None NR In the D+ group, 

there were 

19 operations in 

the 18 patients.

Diabetes was 

more common in 

D+ recipients 

(5/18) than 

D- recipients 

(1/10).

D+ recipients were 

significantly older 

(46 vs. 35).

D+ recipients rate 

of antiCMV was 

higher (87% vs. 

50%).

Mismatching of 

HLA-A and HLA-B 

was higher in the 

D+ recipients 

(3.2 vs. 2.3).
463

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Patient 

survival

Median: 16,

Mean: 15 

(standard 

error of the 

mean: 2), 

Range:

3-33

94%

(17/18)

90%

(9/10)

None NR In the D+ group, 

there were 

19 operations in 

the 18 patients.

Diabetes was more 

common in D+ 

recipients (5/18) 

than D- recipients 

(1/10).

D+ recipients were 

significantly older 

(46 vs. 35).

D+ recipients rate 

of antiCMV was 

higher (87% vs. 

50%).

Mismatching of 

HLA-A and HLA-B 

was higher in the 

D+ recipients (3.2 

vs. 2.3).

Ali et al. (1998)99 Graft 

survival

Mean 36,

Range:

12-60

50%

(14/28)

31%

(5/16)

None p-value was 

reported as 

p >0.3. However 

the chi-squared 

test yields 

p = 0.23.
464

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Morales et al. (1995)87 Graft 

survival

26 months 

(SD: 8) for 

those who 

received a 

positive 

organ, 

and 

30 months 

(SD: 10) for 

those who 

received a 

negative 

organ

96%

(23/24)

93%

(37/40)

None n.s. Number of blood 

transfusions less in 

D+ recipients 

(7 vs. 21); p <0.05.

Patient 

survival

26 months 

(SD: 8) for 

those who 

received a 

positive 

organ, 

and 

30 months 

(SD: 10) for 

those who 

received a 

negative 

organ

100%

(24/24)

98%

(39/40)

None n.s. Number of blood 

transfusions less in 

D+ recipients 

(7 vs. 21); p <0.05.

Saab et al. (2003)91 Patient 

survival

12 89%

(N = NR)

87%

(N = NR)

None p = 0.22 

comparing the 

survival curves

Patient 

survival

36 89%

(N = NR)

79%

(N = NR)

None p = 0.22 

comparing the 

survival curves

Patient 

survival

60 89%

(N = NR)

69%

(N = NR)

None p = 0.22 

comparing the 

survival curves
465

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Graft 

survival

12 73%

(N = NR)

78%

(N = NR)

None p = 0.77 

comparing the 

survival curves

Graft 

survival

36 73%

(N = NR)

70%

(N = NR)

None p = 0.77 

comparing the 

survival curves

Graft 

survival

60 73%

(N = NR)

59%

(N = NR)

None p = 0.77 

comparing the 

survival curves

Velidedeoglu et al. 

(2002)93,94 Penn data

Graft 

survival

12 69.2%

(N = 13)

79.6%

(N = 103)

None p-value

comparing graft 

survival curves 

was p = 0.6778

These data refer to 

patients seen at 

Penn

Graft 

survival

36 69.2%

(N = NR)

71.6%

(N = NR)

None p-value

comparing graft 

survival curves 

was p = 0.6778

These data refer to 

patients seen at 

Penn

Graft 

survival

60 69.2%

(N = NR)

61.2%

(N = NR)

None p-value

comparing graft 

survival curves 

was p = 0.6778

These data refer to 

patients seen at 

Penn

Patient 

survival

Mean: 23.4 77%

(10/13)

78.7%

(81/103)

None NR These data refer to 

patients seen at 

Penn
466

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Velidedeoglu et al. 

(2002)93,94 UNOS data

Graft 

survival

12 76.9%

(N = 190)

80.6%

(N = 5,053)

None p-value

comparing graft 

survival curves 

was p = 0.965

These data refer to 

patients from 

UNOS

Graft 

survival

36 72.6%

(N = NR)

69.1%

(N = NR)

None p-value

comparing graft 

survival curves 

was p = 0.965

These data refer to 

patients from 

UNOS

Graft 

survival

60 69.3%

(N = NR)

62.2%

(N = NR)

None p-value

comparing graft 

survival curves 

was p = 0.965

These data refer to 

patients from 

UNOS

Marroquin et al. (2001)90 Patient 

survival

6 95%

(N = NR)

85%

(N = NR)

None p = 0.01 for the 

comparison of 

patient survival 

curves

Recipients of 

positive organs 

were more likely to 

have liver cancer 

(8.3% vs. 3.1%; 

p = 0.01), 

more likely to have 

ABO incompatibility 

(4.2% vs. 1.3%; 

p = 0.04), and they 

had poorer waitlist 

status (see Table 5 

in the publication).

Patient 

survival

12 90%

(N = NR)

82%

(N = NR)

None p = 0.01 for the 

comparison of 

patient survival 

curves

Recipients of 

positive organs 

were more likely to 

have liver cancer 

(8.3% vs. 3.1%; 

p = 0.01), 

more likely to have 

ABO incompatibility 

(4.2% vs. 1.3%; 

p = 0.04), and they 

had poorer waitlist 

status (see Table 5 

in the publication).
467

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Patient 

survival

18 90%

(N = NR)

79%

(N = NR)

None p = 0.01 for the 

comparison of 

patient survival 

curves

Recipients of 

positive organs 

were more likely to 

have liver cancer 

(8.3% vs. 3.1%; 

p = 0.01), more 

likely to have ABO 

incompatibility 

(4.2% vs. 1.3%; 

p = 0.04), and they 

had poorer waitlist 

status (see Table 5 

in the publication).

Patient 

survival

24 90%

(N = NR)

77%

(N = NR)

None p = 0.01 for the 

comparison of 

patient survival 

curves

Recipients of 

positive organs 

were more likely to 

have liver cancer 

(8.3% vs. 3.1%; 

p = 0.01), more 

likely to have ABO 

incompatibility 

(4.2% vs. 1.3%; 

p = 0.04), and they 

had poorer waitlist 

status (see Table 5 

in the publication).
468

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Patient 

survival, 

overall

Median 

was 

34 months 

for those 

who 

received a 

positive 

organ, 

and 

37 months 

for those 

who 

received a 

negative 

organ

90%

(86/96)

77%

(2194/2827)

None NR Recipients of 

positive organs 

were more likely to 

have liver cancer 

(8.3% vs. 3.1%; 

p = 0.01), more 

likely to have ABO 

incompatibility 

(4.2% vs. 1.3%; 

p = 0.04), and they 

had poorer waitlist 

status (see Table 5 

in the publication).

Graft 

survival

6 88%

(N = NR)

81%

(N = NR)

None NR Data estimated by 

ECRI Institute from 

Figure 3 in the 

publication. 

Recipients of 

positive organs 

were more likely to 

have liver cancer 

(8.3% vs. 3.1%; 

p = 0.01), more 

likely to have ABO 

incompatibility 

(4.2% vs. 1.3%; 

p = 0.04), and they 

had poorer waitlist 

status (see Table 5 

in the publication).
469

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Graft 

survival

12 76%

(N = NR)

76%

(N = NR)

None NR Data estimated by 

ECRI Institute from 

Figure 3 in the 

publication. 

Recipients of 

positive organs 

were more likely to 

have liver cancer 

(8.3% vs. 3.1%; 

p = 0.01), more 

likely to have ABO 

incompatibility 

(4.2% vs. 1.3%; 

p = 0.04), and they 

had poorer waitlist 

status (see Table 5 

in the publication).

Graft 

survival

18 76%

(N = NR)

72%

(N = NR)

None NR Data estimated by 

ECRI Institute from 

Figure 3 in the 

publication. 

Recipients of 

positive organs 

were more likely to 

have liver cancer 

(8.3% vs. 3.1%; 

p = 0.01), more 

likely to have ABO 

incompatibility 

(4.2% vs. 1.3%; 

p = 0.04), and they 

had poorer waitlist 

status (see Table 5 

in the publication).
470

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Graft 

survival

24 76%

(N = NR)

70%

(N = NR)

None NR Data estimated by 

ECRI Institute from 

Figure 3 in the 

publication. 

Recipients of 

positive organs 

were more likely to 

have liver cancer 

(8.3% vs. 3.1%; 

p = 0.01), more 

likely to have ABO 

incompatibility 

(4.2% vs. 1.3%; 

p = 0.04), and they 

had poorer waitlist 

status (see Table 5 

in the publication).

Graft 

survival, 

adjusted 

odds

3 0.7 See previous 

column

Adjusted for 

sex/age/weight of 

both donor and recipient, 

ABO incompatibility, 

coexisting diseases, 

change in liver function 

tests, 

immunosuppressive 

regimens, causes of 

graft failure, 

UNOS status at time of 

transplant, ICU length of 

stay, hospital length of 

stay

n.s.
471

Study Outcome Timepoint D+ OutcomeD- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Graft 

survival, 

adjusted 

odds

6 0.66 See previous 

column

Adjusted for 

sex/age/weight of both 

donor and recipient, 

ABO incompatibility, 

coexisting diseases, 

change in liver function 

tests, 

immunosuppressive 

regimens, causes of 

graft failure, UNOS 

status at time of 

transplant, ICU length of 

stay, hospital length of 

stay

n.s.

Graft 

survival, 

adjusted 

odds

121 See previous 

column

Adjusted for 

sex/age/weight of 

both donor and recipient, 

ABO incompatibility, 

coexisting diseases, 

change in liver function 

tests, immuno-

suppressive regimens, 

causes of graft failure, 

UNOS status at time of 

transplant, ICU length of 

stay, hospital length of 

stay

n.s.

Graft 

survival, 

adjusted 

odds

24 0.88 See previous 

column

Adjusted for 

sex/age/weight of 

both donor and recipient, 

ABO incompatibility, 

coexisting diseases, 

change in liver function 

tests, immuno-

suppressive regimens, 

causes of graft failure, 

UNOS status at time of 

transplant, ICU length of 

stay, hospital length of 

stay

n.s.
472

Study Outcome Timepoint D+ OutcomeD- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Patient 

survival, 

adjusted 

odds

3 0.37 See previous 

column

Adjusted for 

sex/age/weight of 

both donor and recipient, 

ABO incompatibility, 

coexisting diseases, 

change in liver function 

tests, immuno-

suppressive regimens, 

causes of graft failure, 

UNOS status at time of 

transplant, ICU length of 

stay, hospital length of 

stay

n.s.

Patient 

survival, 

adjusted 

odds

6 0.39 See previous 

column

Adjusted for 

sex/age/weight of 

both donor and recipient, 

ABO incompatibility, 

coexisting diseases, 

change in liver function 

tests, immuno-

suppressive regimens, 

causes of graft failure, 

UNOS status at time of 

transplant, ICU length of 

stay, hospital length of 

stay

n.s.

Patient 

survival, 

adjusted 

odds

12 0.56 See previous 

column

Adjusted for 

sex/age/weight of 

both donor and recipient, 

ABO incompatibility, 

coexisting diseases, 

change in liver function 

tests, immuno-

suppressive regimens, 

causes of graft failure, 

UNOS status at time of 

transplant, ICU length of 

stay, hospital length of 

stay

n.s.
473

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Patient 

survival, 

adjusted 

odds

24 0.51 See previous 

column

Adjusted for 

sex/age/weight of 

both donor and recipient, 

ABO incompatibility, 

coexisting diseases, 

change in liver function 

tests, immunosuppressive regimens, 

causes of graft failure, 

UNOS status at time of 

transplant, ICU length of 

stay, hospital length of 

stay

n.s.

Salizzoni et al. (2001)88 Patient 

survival

12 83.3%

(N = NR)

82.4%

(N = NR)

None n.s.

Graft 

survival

12 83.3%

(N = NR)

79.8%

(N = NR)

None n.s.

Vargas et al. (1999)92 Graft 

survival

NR 87%

(20/23)

91%

(154/169)

None n.s.

Patient 

survival

12 89%

(N = NR)

88%

(N = NR)

None n.s.

Patient 

survival

60 72%

(N = NR)

73%

(N = NR)

None n.s.

Testa et al. (1998)89 Graft 

survival

48 71.9%

(N = NR)

76.2%

(N = NR)

None n.s.

Patient 

survival

48 83.9%

(N = NR)

79.1%

(N = NR)

None n.s.
474

Study Outcome Timepoint D+ Outcome D- Outcome

Adjustment for 

Comorbidities

Statistical Test 

Result Comments

Patient 

survival

40 months 

(Range:

12-58) for 

those who 

received a 

positive 

organ, 

and 

36 months 

(Range:

17-135) for 

those who 

received a 

negative 

organ

82%

(18/22)

81%

(93/115)

None n.s.

Shah et al. (1993)12 Graft 

survival

24 80%

(4/5)

70%

(N = NR)

None n.s.

Patient 

survival

24 100%

(N = NR)

80%

(N = NR)

None n.s.

NR – Not reported

n.s. – Not statistically significant
475

Evidence Reviews: V. Potential risks and benefits of 

transplanting, or not transplanting, solid organs from donors

with risk factors for HIV, HBV, or HCV

Question 8. How do the clinical outcomes of transplant recipients who 

receive organs from donors with behavioral or nonbehavioral risk 

factors compare to those who remain on the transplant list?

This question is similar to Question 7, however, Question 7 involved the use of an organ known to be

infected, whereas Question 8 involves an organ from a donor at increased risk of infection. Some 

individuals may test negative for HIV/HBV/HCV and yet have the virus (possibly due to the window 

period for virus detection, or because of test insensitivity).

Two studies met the inclusion criteria (Schweitzer et al. [2007]

203 and Freeman and Cohen [2009]204). 

Both performed simulations on the key dilemma of whether to use organs from serologically negative 

donors who have behavioral risks of infection. The two studies, however, made different comparisons, 

and so they were considered separately. Schweitzer et al. (2007)

203 estimated mortality after transplanting 

the kidneys vs. keeping patients on the waitlist. Freeman and Cohen (2009)204 estimated waitlist mortality 

rates, however they did not estimate mortality of all who received organs from at-risk donors. Instead, 

they reported the overall prevalence of infection among recipients of organs from at-risk donors (which 

was exceedingly low), and then estimated mortality just for infected recipients. Both studies are described 

in more detail in the sections below.

Due to the small amount of evidence, we also looked for studies comparing the clinical outcomes of two 

types of recipients: recipients of organs from at-risk donors, and recipients of organs from not-at-risk 

donors (these donors may or may not have been infected). We defined “at risk” for this question as having 

a potential behavioral risk factor, or having a clinical symptom/physical finding associated with infection, 

or having a medical comorbidity associated with infection. No such comparative studies were identified.

Schweitzer et al. (2007)203

This simulation addressed the question: Should the kidneys of negative-serology donors who are at 

increased risk of infection based on 1994 CDC criteria be transplanted or discarded? Authors constructed

a complicated Markov model of these two alternatives. They considered four types of increased-risk 

donors (IRDs): intravenous drug users (IDU), men who have sex with men (MSM), commercial sex 

workers (CSW), and prison inmates. The authors’ methods, our quality assessment, and study results are 

detailed in the text below, as well as in Table 69 through Table 75.
476

The model considered a 20-year interval, with one-year cycles. During each year, each simulated patient 

was in one of nine states:

Recipient 

HIV status

Recipient 

HCV status

1) On the waitlist HIV- HCV2) Received a kidney HIV- HCV3) On the waitlist HIV+ HCV4) On the waitlist HIV- HCV +

5) On the waitlist HIV + HCV +

6) Received a kidney HIV + HCV7) Received a kidney HIV- HCV +

8) Received a kidney HIV + HCV +

9) Dead

Each of the first eight health states was associated with a different death rate, a different quality-of-life, 

and a different cost of care. For simplicity, authors assumed that all recipients were immune to acute 

HBV infection, which explains why none of the nine states involve HBV status. Transition probabilities 

between states were based on various assumptions using the published literature (see Table 69 through 

Table 71 below).

The epidemiology assumptions listed in Table 70 and Table 71 can be compared informally with the 

corresponding estimates in Question 1 of this evidence review. For HIV, the incidence estimates matched 

closely (Schweitzer assumed 0.02 per 100 person-years, and the estimate in Question 1 was 0.019 per 

100 person years). However, the prevalence of HIV was about one-third of the estimate from Question 1 

(0.128% vs 0.37%). Also, for HCV, the incidence rates were very different (Schweitzer assumed 

0.11 cases per 100 person-years but in Question 1 the estimate was 0.057 per 100 person-years). For HCV 

prevalence, the assumed 1.8% was within the range of estimates from Question 1 (1.3% to 1.9%).

The base case simulation assumed that the CDC-IRD donors were all seronegative injection drug users, 

and the results appear in Table 72. The transplant strategy resulted in lower mortality, more qualityadjusted life-years (QALYs), and also lower cost. There were more HIV infections using the transplant 

strategy, but the number of them was too small (and the resulting health problems not severe enough) to 

overcome the advantages of transplantation. Interestingly, with HCV, there were actually more infections 

with the discard strategy. This was because the discard strategy led to more time on hemodialysis than the 

transplant strategy; the assumed incidence of HCV when on hemodialysis (0.34 per 100 patient-years) 

was 30 times higher than the assumed incidence of HCV after kidney transplant (0.011 per 100 patientyears; see the bottom two rows of Table 71).

Authors performed separate analyses for three other types of increased-risk donors (MSM, CSW, and 

inmates); results were very similar to the base case for outcomes such as the number of transplants, 
477

survival, QALYs, and costs. There were some differences, however, regarding HIV and HCV infections 

(Table 73). Infection counts due to the use of kidneys from MSM or inmates were low for both HIV and 

HCV. The counts for CSW were somewhat higher, but even for this subgroup the total number of 

infections using the transplant strategy (13.7, comprised of 3.4 HIV and 9.3 HCV) was still lower than the 

total number of infections using the discard strategy (14.8, comprised of 1.9 HIV and 12.9 HCV).

Authors conducted numerous one-way sensitivity analyses (in which a single assumption is altered and 

all others left unchanged), and they stated that in most cases the conclusions of the base case “were not 

substantially changed”. They did note that the number of HCV infections was strongly influenced by 

assumptions about incidence rates, but concluded that “the ‘Discard’ policy would yield fewer HCV 

infections only in a setting where a recipient’s risk of infection on dialysis is very low, while the 

probability of CDC-IRD infection in a donor is high”.

203

Authors also conducted a “worse-case scenario” analysis that used the following alternate assumptions:

- That CDC-IRD donors have much higher HIV incidence (25 per 100 person-years) and HIV 

prevalence (50%) than assumed in the base case analysis (2 per 100 person-years, and 18%, 

respectively)

- That CDC-IRD donors have higher HCV incidence (25 per 100 person-years) and HCV prevalence 

(50%) than assumed in the base case analysis (21 per 100 person-years, and 38%, respectively)

- While on the waitlist, the risk of HCV is much lower (0.1 infections per 100 person-years instead of 

the 0.34 assumed in the base case)

- Lower chance of an individual receiving an offer of a CDC-IRD kidney because of increased number 

of eligible individuals for those kidneys (30% instead of the base case 5%)

- Lower percentage of CDC-IRD kidneys (2% of donors instead of 5%)

- Higher cost associated with HIV or HCV infection ($30,000/year instead of $21,000)

- Lower utility associated with HIV or HCV infection (0.45 instead of 0.78 for HIV and 0.82 for HCV)

Interestingly, even though these assumptions were slanted against the Transplant strategy, it still was 

preferable to the discard strategy, resulting in more transplants, less time on the waitlist, more time with a 

functioning transplant, lower mortality, more QALYs, and lower cost.

Finally, because NAT testing may not be widely available, authors also modeled a scenario where only 

antibody testing was available, lengthening the window period for HIV to 22 days from 11; lengthening 

the window period for HCV to 70 days from 10). Results still favored the transplant strategy for all 

outcomes except the number of infections, which rose to 2.6 HIV infections per 1,000 patients and 

27.7 HCV infections per 1000 patients. These additional infections were not sufficient to overcome the 

overall advantages of the transplant strategy.

The GRADE evidence profile appears in Table 76. The evidence was rated as Very Low, because this 

was a simulation and not an empirical study. The GRADE system does not consider simulations as 

informative as empirical studies.
478

Table 69. Assumptions in the Schweitzer et al. (2007) Model

Key Assumptions about Donors

• Deceased donors only

• All donors tested negative on antibody and nucleic amplification tests (NAT) for both HIV and HCV. NAT has a relatively short window 

period (i.e., the duration when it cannot detect the virus), so it would be relatively unlikely to miss a virus for this reason.

• 5% of donors are classified as “CDC-IRD” (IRD = increased risk donor; sensitivity analyses ranging 2%-8%), defined as being in one of the 

seven categories in the 1994 CDC guideline on HIV. 

Key Assumptions about Recipients

• 50-year old hemodialysis patients (sensitivity analyses ranging from 18-65)

• All recipients were willing to accept kidneys from CDC-IRDs.

• All recipients were immune to “acute HBV infection”. Thus if any donor were HBV+, this had no impact on the analysis.

• In any given year, a recipient could acquire either HIV or HCV, but not both. They could acquire the other one in subsequent years.

• 5% of patients on waitlist would be candidates for CDC-IRD kidney (sensitivity analyses ranging from 1%-30%)

• Number of patients on the waitlist at the end of 2002 was 50,535

• Annual number of standard deceased donor kidney transplants in 2002 was 8,288

• Median time to transplant for new waiting list registrants was 3.5 years

• Annual standard donor kidney transplant rate was 20% (sensitivity analyses ranging 2%-53%

• Median waiting time for CDC-IRD kidney transplants was 3.5 years

Key Assumptions about Death Rates

• Annual death rate among all patients on the U.S. kidney waitlist was 3.7% for those 18-34; 5.4% for those aged 35-49; 9.2% for those 

aged 50-64; and 12.9% for those aged 65+

• Annual death rate in the first year after kidney transplant was 2.3% for those 18-34; 3.9% for those aged 35-49; 8.0% for those aged 50-64; 

and 11.6% for those aged 65+

• Annual death rate in all subsequent years after kidney transplant was 2.1% for those 18-34; 2.3% for those aged 35-49; 4.0% for those 

aged 50-64; and 7.2% for those aged 65+

• Relative risk of death due to HIV infection was 1.5

• Relative risk of death due to HCV infection was 1.7
479

Key Assumptions about Costs and Quality-Adjusted-Life-Years (QALYs)

• Costs in 2002 dollars, adjusted using the medical care component of the consumer price index

• Cost of “Stat HIV” and HCV nucleic acid testing (NAT) were estimated at $500/donor or $250/kidney was added to the cost when the donor 

was CDC-IRD

• Cost of hemodialysis $61,000/year (sensitivity analyses ranging from) (sensitivity analyses ranging from $49,000-$71,000)

• Cost of care of kidney recipient in the first year after transplant $97,000/year (sensitivity analyses ranging from $76,000-$177,000)

• Cost of care kidney recipient in all subsequent years $21,000/year (sensitivity analyses ranging from $17,000-$38,000)

• Cost of care for HIV infection was $21,000/year (sensitivity analyses ranging from $19,000-$23,000)

• Cost of care for HCV infection was $2,000/year (sensitivity analyses ranging from $1,000-$30,000)

• Utility of being on hemodialysis was 0.57 (0 denotes death, 1 denotes perfect) (sensitivity analyses ranging from 0.41-0.64)

• Utility of post-transplant quality-of-life was 0.70 (0 denotes death, 1 denotes perfect) (sensitivity analyses ranging from 0.62-0.82)

• Utility of HIV was 0.82 (0 denotes death, 1 denotes perfect) (sensitivity analyses ranging from 0.45-1.00)

• Utility of HCV was 0.78 (0 denotes death, 1 denotes perfect) (sensitivity analyses ranging from 0.60-0.86)

• Discounting of both costs and QALYs at 3%

Other Assumptions

• Overall risk of graft failure after kidney transplant was 6% in the first year (sensitivity analyses ranging from 4%-7%), and 4% in 

subsequent years (sensitivity analyses ranging from 2%-6%). After graft failure, the patient returned to one of the waitlist health states.

• Relative risk of graft failure specifically due to HIV infection was 1.0 (sensitivity analyses ranging from 1.0 to 1.3)

• Relative risk of graft failure specifically due to HCV infection was 1.6 (sensitivity analyses ranging from 1.4 to 1.8)

• The window period for HIV antibody testing alone was 22 days; for HIV antibody plus NAT was 11 days; for HCV antibody alone was 

70 days; for HCV antibody plus NAT was 10 days

• The false-negative rate for pre-transplant serological testing of CDC-IRDs donors was 5%. Together with the window period, this 

incorporated the possibility of missed viruses.
480

Table 70. HIV Epidemiology Assumptions in the Schweitzer et al. (2007) Model

HIV Incidencea Prevalence

Population Base Case

Sensitivity 

Range Base Case

Sensitivity 

Range

General population 0.02 N.A. 0.128% N.A.

Potential Donors

Intravenous drug users 2 1-3 18% 1-49

Men who have sex with men 3 1-12 25% 0-40

Commercial sex workers 10 3-30 24% 0-60

Inmates 0.2 0-0.4 2% 1-17

Potential Recipients

Hemodialysis patients 0.02 N.A. N.E. N.E.

Kidney transplant patients 0.02 N.A. N.E. N.E.

a Incidence is the number of new cases per 100 patient-years.

N.A. – Not applicable because no sensitivity analysis of this parameter was performed.

N.E. – Not estimated, because the model did not require estimates of the prevalence of HIV or HCV among recipients.

Table 71. HCV Epidemiology Assumptions in the Schweitzer et al. (2007) Model

HIV Incidencea Prevalence

Population Base Case

Sensitivity 

Range Base Case

Sensitivity 

Range

General population 0.011 N.A. 1.8% N.A.

Potential Donors

Intravenous drug users 21 10-45 38% 10-90

Men who have sex with men 0.2 0-1 4% 2-18

Commercial sex workers 10 5-23 12% 6-45

Inmates 1 0.3-6 23% 16-41

Potential Recipients

Hemodialysis patients 0.34 0.1-3 N.E. N.E.

Kidney transplant patients 0.011 N.A. N.E. N.E.

a Incidence is the number of new cases per 100 patient-years.

N.A. – Not applicable because no sensitivity analysis of this parameter was performed.

N.E. – Not estimated, because the model did not require estimates of the prevalence of HIV or HCV among recipients.
481

Table 72. Base Case Results of the Schweitzer et al. (2007) Model

Outcome Transplant Discard

Number of kidney transplants 

per 1,000 patients

Total: 990

Standard donors: 495

CDC-IRD donors: 495

Total: 740, all standard donors

Survival 1-year: 91%

5-year: 68%

10-year: 49%

20-year: 23%

1-year: 91%

5-year: 65%

10-year: 45%

20-year: 20%

Quality-adjusted life-years 5.6 5.1

Cost of care over 20 years for 

a typical patient

$338,000 $363,000

HIV infections per 

1,000 patients over 20 years

2.3, comprising 1.9 infections 

when on the waitlist or 

community acquired, and 

0.3 from window-period 

CDC-IRD donations (these 

do not add to 2.3 due to 

rounding)

1.9, all while on the waitlist or 

community-acquired 

HCV infections per 

1,000 patients over 20 years

10.8*, comprising 7.9 infections 

when on the waitlist or 

community acquired, and 

2.9 from window-period 

CDC-IRD donations

12.9*, all while on the waitlist or 

community-acquired

CDC-IRD – CDC increased-risk donor

*The reason that there were actually more HCV infections using the discard strategy is that the discard strategy led to 

more time on hemodialysis than the transplant strategy; the assumed incidence of HCV when on hemodialysis (0.34 

per 100 patient-years) was 30 times higher than the assumed incidence of HCV after kidney transplant (0.011; 

see the bottom two rows of Table 71).
482

Table 73. HIV and HCV Infection Results in Recipients of Kidneys from CDC-IRD Donors

Outcome

HIV HCV

Total

Waitlist or

Community 

Acquired

TransplantAcquired Total

Waitlist or 

Community 

Acquired

TransplantAcquired

Injection drug users 

(base case)

2.3* 1.9 0.3 10.8 7.9 2.9

Men who have sex 

with men

2.4 1.9 0.5 8.0 7.9 0.1

Commercial sex 

workers

3.4 1.9 1.5 9.3 7.9 1.4

Prison inmates 2.0 1.9 0.1 8.1 7.9 0.2

*All numbers are the number of infections per 1,000 patients, all in the Transplant group willing to receive kidneys 

from CDC increased-risk donors. Due to rounding, numbers in the two columns “Waitlist or community acquired” and 

“Transplant-acquired” may not add up exactly to the numbers in the Total column.
483

Freeman and Cohen (2009)204

This study was a comprehensive risk analysis of numerous considerations pertaining to solid organ 

donation. Authors emphasized that the risk of transmitting an infection to a recipient is only one among a 

set of competing risks, including the risk of dying while on the waitlist, the risk of dying after the 

transplant (regardless of the donor’s status), and risks of dying from medications, employment, 

transportation, and recreation. Taking this broad perspective, the authors provided real-world context to 

critical decisions about organ donation.

Most of the data reported in the article did not address this particular research question. These include 

data on the transmission of other pathogens or conditions (e.g., CMV), mortality risks after receiving an 

organ from an extended-criteria kidney or a standard criteria kidney, and everyday mortality risks. This 

question specifically involves the comparison of the clinical outcomes (e.g., mortality rates) of two types 

of potential recipients: 1) those who remained on the waitlist, and 2) those who received organs from atrisk donors. For at-risk donors, the study only addressed mortality after HIV (see Table 3 of the article; 

a row for “High risk donors” appears in the HIV section).

The waitlist mortality estimates are reproduced in Table 74 below. These were based on the authors’

Markov model that utilized 90-day waitlist mortality and transplantation probabilities from the 

OPTN/SRTR 2007 Annual Report. Authors reported rates separately for 12 different types of recipients 

(see table). Three-year estimates were also provided for kidney recipients. For confirmation, ECRI 

Institute replicated the reported results using the reported probabilities using TreeAge Pro (TreeAge 

Software Inc., Williamstown, MA).

The GRADE evidence profile appears in Table 76; the evidence was rated as Very Low, because it was a

simulation; the GRADE rating system provides higher ratings to empirical studies.
484

Table 74. Waitlist Mortality Estimates by Freeman and Cohen (2009)

Type of Recipient

1-year Estimated 

Waitlist Mortality

3-year Estimated 

Waitlist Mortality

Kidney recipient, age 18-34 2.7% 9.8%

Kidney recipient, age 35-49 4.6% 17.2%

Kidney recipient, age 50-64 7.5% 28.0%

Kidney recipient, age 65+ 10.5% 40.3%

Liver recipient, Model for End-Stage Liver Disease (MELD) 

score 10 or less

4.1% NR

Liver recipient, MELD score 11-14 7.1% NR

Liver recipient, MELD score 15-20 11.4% NR

Liver recipient, MELD score 21-30 18.5% NR

Liver recipient, MELD score 31+ 37.1% NR

Heart recipient, status 2 5.9% NR

Heart recipient, status 1B 13.6% NR

Heart recipient, status 1A 21.8% NR

NR – Not reported.

Note: These data are from Table 3 of the Freeman and Cohen article.204 Other data in that table (such as one-year 

mortality after receiving an immediate extended-criteria kidney, and one-year mortality after receiving an 

immediate standard-criteria kidney, liver or heart) do not address Question 8 of this evidence review, and 

therefore are not included in this table.

For consideration of at-risk donors, authors stated that “The 2,189 CDC ‘high-risk’ donors since 2004 

have resulted in 1 HIV positive donor, corresponding to an infection risk of 46 per 100,000.”(footnote b 

of Table 3 of the article)204 In a conservative analysis, they assumed that HIV is 100% fatal, and therefore 

estimated that the HIV-related mortality per 100,000 recipients of organs from at-risk donors was 46 in 

100,000. This corresponds to 0.046%, which is much lower than all of the waitlist mortality rates in 

Table 74 (the lowest in the entire table is 2.7%, which is 59 times higher than HIV-related mortality after

receiving organs from at-risk donors). The authors concluded that the waitlist mortality risk far outweighs 

the risk of HIV-related mortality associated with receiving an organ from a serologically negative donor 

with a behavioral risk factor. They did not attempt to make mortality estimates for either HBV or HCV 

due to insufficient documentation in the literature regarding the mortality rate for infected recipients.
485

Table 75. Questions 8/9: Quality Assessment

Study

8a or 

9a

8b or 

9b

8c or 

9c

8d or 

9d

8e or 

9e

8f or 

9f

8g or 

9g

8h or 

9h

Schweitzer et al. (2007)203 Simulation

Freeman and Cohen (2009)204    

The Schweitzer et al. (2007)203 article was not assessed with these items because it was a simulation rather than a study 

enrolling patients. Extensive details about this simulation appear in the text for Question 8. A checkmark () means that 

the study met the quality criterion for this Question; the lack of a checkmark means that the study either did not meet the 

criterion, or it was unclear whether the study met the criterion. The criteria specific to this Question were: 

8a. Were the patients randomly assigned to treatments?

8b. Was the study planned prospectively (i.e., before any data were collected)

8c. Were all consecutive patients enrolled (or a random sample of eligible patients)?

8d. Were the two groups comparable at baseline? (age, sex, comorbidities, indication for transplant, previous 

duration on waitlist)

8e. If not, were statistical adjustments performed to control for baseline differences? 

8f. Were the two groups treated concurrently?

8g. Did at least 85% of the study enrollees provide data?

8h. Was the between-group difference in study completion rates less than 15%?
486

Table 76. GRADE Table for Question 8 (Clinical Outcomes of At-risk Organs vs. Waitlist or Not-at-risk Organs)

Comparison Outcome

Quantity and 

Type of 

Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE 

of 

Evidence 

for 

Outcome

Overall 

GRADE 

of 

Evidence 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose R

Base

esponse

Confounders would reduce the effect

Transplant vs. 

discard kidneys 

from at-risk 

donors who test 

negative

Recipient 

survival

One 

simulation203

91% survival in 

both groups at 

one year.

At five years, 

survival was 68% 

for the transplant 

group and 65% for 

the discard group.

At 10 years, 

survival was 49% 

for the transplant 

group and 45% for 

the discard group.

At 20 years, 

survival was 23% 

for the transplant 

group and 20% for 

the discard group.

Very 

Low

0 -1 0 0 0 0 0 0 Very Low

Very Low

Quality of 

life

One 

simulation203

5.6 QALYs for the 

transplant strategy, 

compared to 

5.1 QALYs for the 

discard strategy

Very 

Low

0 -1 0 0 0 0 0 0 Very Low
487

Comparison Outcome

Quantity and 

Type of 

Evidence Findings

Starting Grade

Decrease GRADE Increase GRADE

GRADE 

of 

Evidence 

for 

Outcome

Overall 

GRADE 

of 

Evidence 

Study QualityConsistency

Directness

Precision

Publication BiasLarge MagnitudeDose R

Base

esponse

Confounders would reduce the effect

Waitlist survival 

vs. survival of 

infected recipients 

of at-risk organs

Recipient 

survival

One 

simulation204

One-year waitlist 

mortality for 

kidneys was 3% to 

11% (increasing 

with age); for livers 

it was 4% to 37% 

(increasing with 

MELD score); for 

hearts it was 6% to 

22% (increasing 

with criticality 

status). No 

mortality estimates 

provided for all 

those who received 

at-risk organs. Of 

2,189 ‘high-risk’

donors, there was 

only one confirmed 

cases of HIV 

infection.

Very 

Low

0 -1 0 0 0 0 0 0 Very Low Very Low
488

Question 9. What is the impact of excluding potential solid organ donors 

with behavioral or nonbehavioral risk factors on the organ donor pool?

The exclusion of any potential donors, if employed, would reduce the size of the organ donor pool. This 

question is intended to quantify the size of that potential reduction if exclusion were based on the 

presense of a risk factor for HIV, HBV, or HCV. One study was included for this question (Schweitzer et 

al. (2007).

203 This simulation study was described in great detail under Question 8.

Over a 20-year period, the simulation estimated that if at-risk kidneys were excluded from transplantation, 

there would only be 740 transplanted kidneys per 1,000 patients, instead of 990 if at-risk donors were 

included in the pool. Thus 250 fewer kidneys would have been transplanted. This is a reduction of 25.3% 

(250/990). Note that the study only considered four types of behavioral exclusions (IDU, MSM, CSW, 

and prison inmates), and furthermore the study considered only HIV and HCV. Exclusions for other 

reasons (e.g., HBV risk, or nonbehavioral risk factors for HIV or HCV) would mean a larger reduction in 

the organ donor pool.
489

Question 10. What is the impact of false positive tests on the organ donor 

pool?

No studies were identified that met the inclusion criteria. 
490

Gaps in the Current Literature

This systematic review uncovered numerous gaps in the literature about the possible transmission of HIV, 

HBV, or HCV through solid organ transplantation. This section describes the most prominent gaps.

In Question 1, we sought to identify literature on the prevalence and incidence of HIV, HBV, and HCV 

among people whose organs are being considered for donation. Only four small studies of this population 

were identified, and two involved living relatives wishing to donate solid organs to children, which 

comprise only a small proportion of potential organ donors. None of the studies reported incidence, and

only two of the four studies reported rates of HIV. 

In Question 2, the major gap was the lack of studies of the rate of HIV transmission. This is likely 

because federal regulations prohibit the use of organs from donors testing positive for HIV for transplant.. 

Several important gaps affect the usefulness of the current evidence for Questions 3 and 4. Very little 

literature on potential organ donors exists, and the applicability of data from other populations is unclear. 

In addition, almost no information on children was found, and there is very little information on HBV. 

Nearly all of the studies focused on risk factors for prevalent infection; little information on factors for 

incident infection, including signs and symptoms, has been published. Differentiating dependent from 

independent risk factors was inconsistent. Most of the information on identification of factors came from 

self-report, and the reliability of next-of-kin interviews on highly private and personal behavioral factors 

is brought into question by the sole study of potential tissue donors.

Data on performance of diagnostic tests in potential organ donors is lacking for Question 5. For some of 

the tests, there is no data at all. For many tests, some or most of the data is from analytic validation 

studies and may not be applicable to real-world use. Study of the test in relevant clinical applications, or 

at least reasonably similar applications or populations, is needed to draw strong conclusions regarding the 

‘real-world’ use of these tests in this context. This is also needed to enable the calculation of useful 

statistics including predictive values, likelihood ratios, and post-test probabilities of diseases. 

Question 6, on inactivation, only yielded a single uncontrolled study that had been published in 1994; no 

additional studies of the inactivation of solid organs have appeared since then. The last three questions (8 

through 10) all contained low amounts of evidence, and are all potential targets for future research. 

In Question 7, only one included study had a waitlist control group. Numerous studies used a control 

group of recipients who received organs from negative donors, however, those studies had various quality 

problems (e.g., differing pre-transplant characteristics, without statistical adjustment) that limit the 

interpretability of their results. More comprehensive analyses of competing risks (of both transplanting 

and discarding organs from infected donors) would help inform critical decision making.

Question 8 included only two studies, both of which estimated survival on the waitlist using Markov 

models. One of them also provided data for Question 9 on the size of reduction in the organ donor pool, 

and no studies addressed Question 10.
491

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503

Appendix A

Details of Literature Search

Electronic Database Searches

The following databases have been searched for relevant information:

Table 77. Electronic Databases Searched

Database Date Limits Platform/Provider

The Cochrane Central 

Register of Controlled Trials 

(CENTRAL)

Through 2009, Issue 3 www.thecochranelibrary.com

The Cochrane Database of 

Methodology Reviews 

(Methodology Reviews)

Through 2009, Issue 3 www.thecochranelibrary.com

The Cochrane Database of 

Systematic Reviews 

(Cochrane Reviews)

Through 2009, Issue 3 www.thecochranelibrary.com

Database of Abstracts of 

Reviews of Effects (DARE)

Through 2009, Issue 3 www.thecochranelibrary.com

EMBASE (Excerpta Medica) 1990 – July 13, 2009 OVID

Health Technology 

Assessment Database (HTA)

Through 2009, Issue 3 www.thecochranelibrary.com

Healthcare Standards Searched February 10, 2009 ECRI Institute

MEDLINE 1990 – July 13, 2009

Searches for some key questions 

not limited by date

OVID

PreMEDLINE Searched July 13, 2009 OVID

U.K. National Health Service

Economic Evaluation 

Database (NHS EED)

Through 2009, Issue 3 www.thecochranelibrary.com

U.S. National Guideline 

ClearinghouseTM (NGC)

Searched February 10, 2009 www.ngc.gov

Hand Searches of Journal and Nonjournal Literature

Journals and supplements maintained in ECRI’s collections were routinely reviewed. Nonjournal 

publications and conference proceedings from professional organizations, private agencies, and 

government agencies were also screened. Other mechanisms used to retrieve additional relevant 

information included review of bibliographies/reference lists from peer-reviewed and gray literature. 

(Gray literature consists of reports, studies, articles, and monographs produced by federal and local 

government agencies, private organizations, educational facilities, consulting firms, and corporations. 

These documents do not appear in the peer-reviewed journal literature.)
504

Grey Literature Searches

The following resources have been searched for information relevant to specific diagnostic tests:

Resource Date Limits Platform/Provider

Google

(“CE Mark” OR “CE marked” 

OR registered) (test name)

Searched August 8, 2009 www.google.com

Health Protection Agency 

Microbiological Diagnostics 

Assessment Service 

Evaluations

Searched August 7, 2009 www.hpa-midas.org.uk

HealthCanada Searched August 8, 2009 http://www.hc-sc.gc.ca/dhpmps/index-eng.php

Manufacturer Web sites Searched August 8, 2009 www.abbottdiagnostics.com

www.abbott.com

www.abbottdiagnostics.com.au

www.beckman.com

www.bio-rad.com

www.biomerieux.com

www.biomerieux-diagnostics.com

www.chiron.com

www.gen-probe.com

www.innogenetics.be

www.orthoclinical.com

www.roche.com

www.roche-diagnostics.com

www.siemens.com

www.diagnostics.siemens.com

National Serology Reference 

Laboratory

Searched August 7, 2009 www.nrl.gov.au

U.S. Food and Drug 

Administration (FDA) 

Web site

Searched August 6, 2009 www.fda.gov

World Health Organization 

Web site

Searched August 7, 2009 www.who.int/en/
505

Search Strategies

The search strategies employed combinations of free text keywords as well as controlled vocabulary 

terms including (but not limited to) the following concepts. The strategy below is presented in OVID 

syntax; the search was simultaneously conducted across EMBASE, MEDLINE, and PsycINFO. 

A parallel strategy was used to search the databases comprising the Cochrane Library.

Medical Subject Headings (MeSH), EMTREE and Keywords

Conventions:

OVID

$ = truncation character (wildcard) 

exp = “explodes” controlled vocabulary term (e.g., expands search to all more specific related terms

in the vocabulary’s hierarchy)

/ = limit controlled vocabulary heading

.fs. = floating subheading

.hw. = limit to heading word

.md. = type of methodology (PsycINFO)

.mp. = combined search fields (default if no fields are specified)

.pt. = publication type

.ti. = limit to title 

.tw. = limit to title and abstract fields

Dialog 

? = truncation character (wildcard)

! = “explodes” controlled vocabulary term (e.g., expands search to all more specific related terms 

in the vocabulary’s hierarchy)

/de = limit controlled vocabulary heading

pt = publication type

/ti = limit to title

/ti,ab = limit to title and abstract fields
506

Topic-specific Search Terms

Concept Controlled Vocabulary Keywords

Analytic validity Accuracy

Diagnostic accuracy

Exp diagnostic error/

Exp diagnostic errors/

Likelihood

Observer variation

Precision 

Exp Prediction and forecasting/

Predictive value of tests

Receiver operating characteristic

ROC curve

Sensitivity and specificity

Accurate

Accuracy 

Analytic adj2 valid$

Borderline 

Concordance 

False negative

False positive

Intraobserver

Intra-observer

Interobserver

Inter-observer

Interpret$

Kappa

Likelihood 

Observer bias

Observer variability

Observer variation

Precision 

Predict$

Reader$

Reader concordance

Receiver operating 

characteristic

Reliab$

Repeatab$

Replicabil$

ROC

True negative 

True positive

Valid$

Window$ 

WPRT$

Diagnosis Exp diagnosis/

di.fs. (diagnosis)

Diagnos$

Disease transmission Disease transmission/pc

Disease transmission, horizontal/pc

Transmission.fs.
507

Concept Controlled Vocabulary Keywords

Donors Cadaver 

Cadaver donor

Donor 

Kidney donor

Living donor

Living donors

Organ donor

Exp tissue/

Exp Tissue donors/

Exp Tissue and organ procurement/

Exp Transplantation 

Classification.fs.

Supply & distribution.fs.

Donor$

Donat$

Epidemiology eh.fs. (ethnology)

ep.fs. (epidemiology)

prevalence

exp United States/

Epidemiol$

Incidence

Prevalen$

US.ti.

United States

USA.tw.

Risk Exp Anamnesis/

Behavioral risk factor surveillance 

system

High risk behavior

High risk patient

High risk population

Exp Medical history taking/

Medical record review 

Medical records

Exp Physical examination/

Population characteristics

Risk factor

Risk factors

Risk reduction behavior

Risk-taking

Sexual behavior

Substance abuse, intravenous

Unsafe sex

Behavior 

Chart review

Gaol

Haemophilia$

Hemophilia$

High adj2 risk$

Intravenous drug$

IV drug$

Incarcerat$

Inmate$

Injectable drug$

Jail$

MSM

Medical history

Multiple adj2 partner$

Needle adj shar$

Patient history

Penitentiary

Prison$

Risk (in the title)

Sex 

Screening Exp Mass screening/

Exp screening/

Screen$
508

Concept Controlled Vocabulary Keywords

Solid organ & 

tissue transplantation

Allotransplantation 

Exp organ transplantation/

Transplantation, homologous

Tr.fs. (transplantation)

Allograft$

Bone$

Bowel$

Composite vascular

Cornea$

Face$

Hand$

Heart 

Homograft$

Intestin$

Kidney

Liver

Lung$

Ovar$

Pancreas

Solid organ

Testes 

Testicl$

Tissue$

Transplant$

Specific infections Communicable diseases

Hepatitis antigens

Hepatitis b

Hepatitis c

Exp hepatitis b antigen/

Exp hepatitis b antigens/

Exp hepatitis c antigens/

Exp HIV Infections/

HTLV-1 infections 

Exp human immunodeficiency virus

Human immunodeficiency virus 

antigen

Exp human immunodeficiency virus 

infections/

hepatitis

Hepatitis B

Hepatitis C

HIV$

HBV

HCV

Specific publications MMWR morbidity & mortality weekly 

report.jn.
509

Concept Controlled Vocabulary Keywords

Testing DNA microarray

Exp gene amplification/

Exp hybridization/

Exp in situ hybridization/

Microarray analysis

Exp Microarray analysis/

Molecular diagnostic techniques

Exp molecular probe/

Exp molecular probe techniques/

Exp nucleic acid amplification 

techniques/

Exp nucleic acid hybridization/

Serological tests

ADVIA Centaur

AMRAD

anti-p22 antibody test

Architect 

Assay$

AxSYM

Blot

Borderline 

Centaur

COBAS Amplicor

COBAS AmpliScreen

Core

Corecell haemagglutination 

assay

CORZYME

Coulter antigen

Coulter p24

Elecsys

Enzygnost

Genetic$ adj System$

Genscreen

HBsAG

HIVAB

INNOTEST

MATRIX HCV

Monolisa

Murex

NAT

Nucleic acid amplification

NucliSens-AmpliScreen

Occult 

Ortho ELISA

PCR$

PRISM

ProCleix

Qiagen QIAmp

Roche combo

Roche modular

TaqMan

Test$

Uni-Form

VERSANT HCV 

VIDAS DUO

Vironostika 

Virus BioRobot

Vitros

Window$

WPRT$
510

Concept Controlled Vocabulary Keywords

Virus inactivation Exp *antiviral agents/

Exp*antivirus agent/

Virus inactivation

Organ perfusion 

Organ preservation

exp Organ preservation/

Perfusion 

Tissue perfusion 

Tissue preservation

Deactivat$

Inactivat$

Irrigat$
511

Searches

Unless otherwise specified, all searches were limited to human population and by date range 1990 – 2009.

Donor 1966 – 2009

Set 

Number Concept Search Statement

1 Transplantation exp organ transplantation/

2 (((transplantation, homologous or allotransplantation).de. or 

tr.fs.) and (solid organ or heart or lung$ or kidney$ or liver or 

intestin$ or bowel$ or pancreas or face or hand$ or (composite 

adj vascular) or ovar$ or testes or testicl$)) 

3 Exp tissue transplantation/

4 Combine sets or/1-3

5 Donors exp tissue donors/ or exp tissue/ or living donors/ or donor/ or 

kidney donor/ or living donor/ or organ donor/ or cadaver donor/ 

or cadaver/

6 donor$.ti. 

7 6 and (solid organ or heart or lung$ or kidney$ or liver or 

intestin$ or bowel$ or pancreas or face or hand$ or (composite 

adj vascular) or ovar$ or testes or testicl$)

8 Combine sets or/5-7 

9 Combine sets

(tissue donors)

4 and 8

10 Specific infections exp HIV infections/ or exp human immunodeficiency virus 

infections/ or exp hepatitis b antigens/ or exp hepatitis c 

antigens/ or exp hepatitis b antigen/ or (hepatitis b or hepatitis c 

or hepatitis c antigen).de. or (hepatitis adj (b or c) or HIV$)

11 Combine sets 

(Infections and tissue 

transplantation)

9 and 10

13 Limit by publication 

type

12 not (letter/ or editorial/ or news/ or comment/ or note/ or 

conference paper/ or (letter or editorial or news or comment).pt.)

14 Eliminate overlap Remove duplicates from 13
512

Epidemiology (Q1) (2004-2009)

Set 

Number Concept Search Statement

1 Specific infections exp HIV infections/ or exp human immunodeficiency virus 

infections/ or exp hepatitis b antigens/ or exp hepatitis c 

antigens/ or exp hepatitis b antigen/ or (hepatitis b or hepatitis c 

or hepatitis c antigen).de. or (hepatitis adj (b or c))

2 Epidemiology 1 and ep.fs.

3 1 and eh.fs.

4 1 and prevalence.de.

5 1 and (prevalen$ or incidence or epidemiol$).ti.

6 Combine sets or/2-5

7 Reviews 6 and review$.ti,de,pt.

8 RCTs

Narrow filter

6 and (random$.ti. or randomized controlled trial.pt.)

9 Limit by publication 

type

6 not (letter/ or editorial/ or news/ or comment/ or note/ or 

conference paper/ or case reports/ or (letter or editorial or news 

or comment or case reports).pt.))

10 Systematic reviews

Broad filter

9 and ((research synthesis or pooled).mp. or review.ti,pt. or 

(systematic review or meta analysis or meta-analysis).de. or 

((evidence base$ or methodol$ or systematic or quantitative$ or 

studies).mp. and (review.de. or review.pt.)))

11 Eliminate overlap Remove duplicates from 10

The retrieval was still too large so we used another approach

12 5 and 11

13 Limit by region 12 and (exp United States/ or United States.tw. or us.ti. or 

usa.ti.)

14 HIV infections as major 

topic

Exp *HIV infections/ep,eh

15 Exp *human immunodeficiency virus infection/ep

16 Hepatitis infection as 

major topic

*hepatitis b/ep or *hepatitis c/ep

17 Combine sets or/15-17

18 Systematic reviews

Broad filter

17 and ((research synthesis or pooled).mp. or review.ti,pt. or 

(systematic review or meta analysis or meta-analysis).de. or 

((evidence base$ or methodol$ or systematic or quantitative$ or 

studies).mp. and (review.de. or review.pt.)))

19 Limit by region 18 and (exp United States/ or United States.tw. or us.ti. or 

usa.ti.)
513

Set 

Number Concept Search Statement

20 Limit by concept 18 and prevalence.ti.

One more another approach

21 Limit by concept 17 and prevalence.ti.

22 21 and (hepatitis or HIV$ or HBV$ or HCV$).ti.

23 Limit by publication 

type

22 not ((letter or editorial or news or comment or case reports or 

note or conference paper).de. or (letter or editorial or news or 

comment or case reports).pt.)

24 Limit by region 23 and (exp United States/ or United States.tw. or us.ti. or 

usa.tw.)

25 Limit by publication 23 and mmwr morbidity & mortality weekly report.jn.

25 Author search (Armstrong$ and Wasley$ and Simard$).au.

26 Related articles search Find articles related to The prevalence of hepatitis C virus 

infection in the United States, 1999 through 2002
514

Inactivation (Q6) – includes animal population

Set 

Number Concept Search Statement

1 Transplantation exp organ transplantation/

2 (((transplantation, homologous or allotransplantation).de. or 

tr.fs.) and (solid organ or heart or lung$ or kidney$ or liver or 

intestin$ or bowel$ or pancreas or face or hand$ or (composite 

adj vascular) or ovar$ or testes or testicl$))

3 Exp tissue transplantation/

4 (((transplantation, homologous or allotransplantation).de. or 

tr.fs.) and (tissue$ or bone$ or allograft$ or homograft$))

5 Combine sets or/1-4

6 Organ donors ((exp tissue donors/ or exp tissue/) and organ procurement/) or 

(living donors or donor or kidney donor or living donor or organ 

donor).de.

7 donor$.ti.

8 7 and (solid organ or heart or lung$ or kidney$ or liver or 

intestin$ or bowel$ or pancreas or face or hand$ or (composite 

adj vascular) or ovar$ or testes or testicl$ or tissue or bone or 

allograft$ or homograft$)

9 Combine sets 6 or 8

10 Combine sets 5 or 9

11 Specific infections exp HIV infections/ or exp human immunodeficiency virus 

infections/ or exp hepatitis b antigens/ or exp hepatitis c 

antigens/ or exp hepatitis b antigen/ or (hepatitis b or hepatitis c 

or hepatitis c antigen).de. or (hepatitis adj (b or c)) or HIV$

12 Infections and 

transplantation

Combine sets

10 and 11

13 Limit by publication 

type

12 not ((letter or editorial or news or comment or case reports or 

note or conference paper).de. or (letter or editorial or news or 

comment or case reports).pt.)

14 Virus inactivation 13 and (Virus inactivation.de. or (inactivat$ or deactivat$).tw.)

15 13 and (Exp *antiviral agents/ or exp *antivirus agent/)

16 13 and irrigat$

17 Combine sets or/14-16

18 Eliminate overlap Remove duplicates from
515

Hepatitis B (1966 – 2009)

Set 

Number Concept Search Statement

1 Hepatitis B Exp hepatitis b antigens/ or exp hepatitis b antigen/ or hepatitis 

b/ or hepatitis b or HBV

2 Diagnosis 1 and (exp diagnosis/ or di.fs. or receiver operating 

characteristic/ or ROC curve/ or sensitivity and specificity/ or 

accuracy/ or diagnostic accuracy/ or precision or exp prediction 

and forecasting/ or likelihood or ((false or true) adj (positive or 

negative)) or predictive value of tests/)

3 Molecular testing 

(EMTREE)

2 and (exp molecular probe/ or exp hybridization/ or exp 

molecular probe/ or exp gene amplification/ or Microarray 

analysis/ or DNA microarray/)

4 Molecular testing 

(MeSH)

2 and (molecular diagnostic techniques/ or exp molecular probe 

techniques/ or exp nucleic acid amplification techniques/ or exp 

nucleic acid hybridization/ or exp in situ hybridization/ or exp 

microarray analysis/)

5 Specific tests ((HBsAg adj2 (Elecsys or AxSYM or Architect or Centaur or 

Enzygnost or Vitros)) or AMRAD or NucliSens-AmpliScreen or 

VERSANT HCV PRISM HCV or anti-p22 antibody test or NAT or 

nucleic acid amplification technology or Cobas Amplicor or 

Qiagen QIAamp or Virus BioRobot or PCR or TaqMan or 

MATRIX HCV or western blot or corecell haemagglutination 

assay).mp,df, dm.

6 Combine sets or/3-5

7 Eliminate overlap Remove duplicates from 6

8 Limit by publication 

type

12 not ((letter or editorial or news or comment or case reports or 

note or conference paper).de. or (letter or editorial or news or 

comment or case reports).pt.)
516

Risk (Q3 and Q4) 7/2/09

Set 

Number Concept Search Statement

1 Specific infections exp HIV infections/ or exp human immunodeficiency virus 

infections/ or exp hepatitis b antigens/ or exp hepatitis c 

antigens/ or exp hepatitis b antigen/ or (hepatitis b or hepatitis c 

or hepatitis c antigen).de. or (hepatitis adj (b or c) or HIV)

2 Donors ((exp tissue donors/ or exp tissue/) and organ procurement/) or 

(living donors or donor or kidney donor or living donor or organ 

donor or cadaver donor or cadaver).de. or donor$ or donat$

3 Risk (risk-taking or risk reduction behavior or behavioral risk factor 

surveillance system or risk factors or population characteristics 

or sexual behavior or unsafe sex or substance abuse, 

intravenous).de.

4 (high risk behavior or risk factor or high risk population or high 

risk patient).de.

5 (high adj2 risk$).ti. or (multiple adj2 partner$) or ((intravenous or 

iv or injectable) adj drug$) or (needle adj shar$) or hemophilia$ 

or haemophilia$ or incarcerat$ or prison$ or gaol or jail$ or 

inmate$ or MSM.tw.

6 Donor history (exp Medical history taking/ or exp Physical examination/ or exp 

Anamnesis/ or exp Physical examination/ or (medical records or 

medical record review).de. or ((Medical or patient) adj history) or 

chart review)

7 Combine sets or/3-6

8 Combine sets 1 and 2 and 6

9 Eliminate overlap Remove duplicates from 7

10 Limit by publication 

type

8 not ((letter or editorial or news or comment or case reports or 

note or conference paper).de. or (letter or editorial or news or 

comment or case reports).pt.)

11 Limit by major concept 10 and (*risk factor/ or *risk factors/ or *risk-taking/ or *high risk 

behavior/)

12 Limit by concept 10 and risk$.ti.

14 Limit by concept 10 and (behavio?r$ or sex$)

15 Combine sets 6 and 10

16 Combine sets or/11-15
517

Screening

Set 

Number Concept Search Statement

1 Specific infections exp HIV infections/ or exp human immunodeficiency virus 

infections/ or exp hepatitis b antigens/ or exp hepatitis c 

antigens/ or exp hepatitis b antigen/ or (hepatitis b or hepatitis c 

or hepatitis c antigen).de. or (hepatitis adj (b or c))

2 Screening 1 and (screen$.ti. or exp screening/ or exp mass screening/) 

3 Limit by publication 

type

2 not ((letter or editorial or news or comment or note or 

conference paper).de. or (letter or editorial or news or 

comment).pt.)

6 Eliminate overlap Remove duplicates from 5

7 Analytic validity of 

tests

6 and (Analytic adj2 valid$)

8 Exp “prediction and forecasting”/

9 6 and 8

10 6 and ((predictive value of tests or receiver operating 

characteristic or ROC curve or sensitivity and specificity or 

accuracy or diagnostic accuracy or precision or likelihood).de. or 

((false or true) adj (positive or negative)))

11 6 and Valid$.ti,ab.

12 6 and ((intraobserver or intra-observer or interobserver or interobserver or interpret$ or kappa or observer bias or observer 

variability or reader$ or reader concordance or reliab$ or 

repeatab$ or replicat$).tw. or observer variation.de.)

13 Combine sets or/7,9-12

14 Donors 13 and ((Living donor or cadaver donor).de. or exp Tissue 

donors/ or exp transplantation/ or donor$ or donat$)

15 exp “Tissue and organ procurement”/ 

16 Combine sets 13 and 15

17 Combine sets 14 or 16

18 Combine sets 13 not 17
518

Specific Tests (Q5)

Set 

Number Concept Search Statement

1 Genetics System (GS) 

HIV 1-1/HIV-2 Plus 0 

EIA

((genetic$ adj system$) and ((HIV$ or HBV$ or HCV$ or HbsAg 

or anti-HB$ or anti-HC$ or HBc$) or Bio-Rad or Biorad).mp.) or 

(genetic$ adj system$).dv.

2 HIVAB HIV-1/HIV-2 

(rDNA) EIA

HIVAB$.mp,dv.

3 AxSYM (AxSYM and (core$ or HIV$ or HBV$ or HCV$ or HbsAg or antiHB$ or anti-HC$ or HBc$)).mp,dv.

4 ADVIA Centaur (ADVIA Centaur and (core$ or HIV$ or HBV$ or HCV$ or HbsAg 

or anti-HB$ or anti-HC$ or HBc$)).mp,dv.

5 PRISM (PRISM and (core$ or HIV$ or HBV$ or HCV$ or HbsAg or antiHB$ or anti-HC$ or HBc$)).mp,dv.

6 CORZYME (CORZYME and (core$ or HIV$ or HBV$ or HCV$ or HbsAg or 

anti-HB$ or anti-HC$ or HBc$)).mp,dv.

7 COBAS AmpliScreen ((COBAS and (core or AmpliScreen)) and (core$ or HIV$ or 

HBV$ or HCV$ or HbsAg or anti-HB$ or anti-HC$ or 

HBc$)).mp,dv.

8 ProCleix HIV-1/HCV (ProCleix and (core$ or HIV$ or HBV$ or HCV$ or HbsAg or 

anti-HB$ or anti-HC$ or HBc$)).mp,dv.

9 VIDAS DUO ((VIDAS and DUO) and (core$ or HIV$ or HBV$ or HCV$ or 

HbsAg or anti-HB$ or anti-HC$ or HBc$)).mp,dv.

10 ARCHITECT (ARCHITECT and (core$ or HIV$ or HBV$ or HCV$ or HbsAg 

or anti-HB$ or anti-HC$ or HBc$)).mp,dv.

11 Genscreen (Genscreen and (core$ or HIV$ or HBV$ or HCV$ or HbsAg or 

anti-HB$ or anti-HC$ or HBc$)).mp,dv.

12 Murex (Murex and (core$ or HIV$ or HBV$ or HCV$ or HbsAg or antiHB$ or anti-HC$ or HBc$)).mp,dv.

13 Enzygnost (Enzygnost and (core$ or HIV$ or HBV$ or HCV$ or HbsAg or 

anti-HB$ or anti-HC$ or HBc$)).mp,dv.

14 Vironostika ((Vironostika or Uni-Form) and (core$ or HIV$ or HBV$ or HCV$ 

or HbsAg or anti-HB$ or anti-HC$ or HBc$)).mp,dv.

15 INNOTEST (INNOTEST and (core$ or HIV$ or HBV$ or HCV$ or HbsAg or 

anti-HB$ or anti-HC$ or HBc$)).mp,dv.

16 Monolisa (Monolisa and (core$ or HIV$ or HBV$ or HCV$ or HbsAg or 

anti-HB$ or anti-HC$ or HBc$)).mp,dv.

17 Ortho ELISA v 3 (Ortho and ELISA and (core$ or HIV$ or HBV$ or HCV$ or 

HbsAg or anti-HB$ or anti-HC$ or HBc$)).mp,dv.

18 Coulter HIV-1 p24 

Antigen Assay

(Coulter and (antigen$ or p24) and (core$ or HIV$ or HBV$ or 

HCV$ or HbsAg or anti-HB$ or anti-HC$ or HBc$)).mp,dv.
519

Set 

Number Concept Search Statement

19 Modular HIV Combo (Roche and (modular or combo) and (core$ or HIV$ or HBV$ or 

HCV$ or HbsAg or anti-HB$ or anti-HC$ or HBc$)).mp,dv.

20 HCV EIA 2.0 (Abbot and EIA and 2$ and (core$ or HIV$ or HBV$ or HCV$ or 

HbsAg or anti-HB$ or anti-HC$ or HBc$)).mp,dv.

21 Combine sets or/1-20

22 Eliminate overlap Remove duplicates from 21

23 Limit by publication 

type

22 not ((letter or editorial or news or comment or case reports or 

note or conference paper).de. or (letter or editorial or news or 

comment or case reports).pt.)

24 Limit to diagnosis & 

screening

23 and (screen$ or diagnos$.tw. or exp diagnosis/ or di.fs. or 

receiver operating characteristic.de. or ROC curve.de. or 

sensitivity and specificity/ or accuracy.de. or diagnostic 

accuracy.de. or precision or exp prediction and forecasting/ or 

exp diagnostic errors/ or exp diagnostic error/ or likelihood or 

((false or true) adj (positive or negative)) or predictive value of 

tests.de.)

25 Window 23 and (window$ or WPRT$).tw. 

26 Combine sets 24 or 25

27 23 and borderline$ 

28 Combine sets 26 or 27

29 23 and occult$

30 Combine sets 28 or 29